FDA Product Code
FDA Product Code FGB — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Gastroenterology, Urology
- 21 CFR Citation
- 876.1500
510(k) Clearances — 119 records · page 1 of 2
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K261447 | CVAC® Aspiration System | Calyxo, Inc. | 2026-09-15 | Traditional | PDF ↗ |
| K262488 | Single-Use Video Flexible Ureterorenoscope (RP-U-C06R9, RP-U-C06R3, RP-U-C06S9, RP-U-C06S3) | Guangzhou Red Pine Medical Instrument Co., Ltd. | 2026-09-09 | Traditional | PDF ↗ |
| K261153 | LithoVue Elite Digital Flexible Ureteroscope System | Boston Scientific Corporation | 2026-08-26 | Traditional | PDF ↗ |
| K262552 | Single-use Flexible Ureteroscope (Single-use Flexible Ureteroscope: SUV-5C-B) | Scivita Medical Technology Co., Ltd. | 2026-08-14 | Special | PDF ↗ |
| K253505 | Zamenix P | Roen Surgical, Inc. | 2026-08-07 | Traditional | PDF ↗ |
| K260516 | BubbleView Single-Use Digital Flexible Cystoscope (C38-CS, C38-CRS, C50-C, C50-CR, C50-CB, C50-CBR) | MacroLux Medical Technology Co., Ltd. | 2026-07-20 | Traditional | PDF ↗ |
| K252929 | Single Use Digital Flexible Ureteroscope (7.5F); Videoscope Imaging Processor (Model HV-200) | Anhui Happiness Workshop Instruments Co., Ltd. | 2026-04-09 | Traditional | PDF ↗ |
| K260013 | CVAC Image Processor | Calyxo, Inc. | 2026-03-06 | Traditional | PDF ↗ |
| K252468 | Single-use Digital Flexible Ureteroscope (GY-UR9.3); Single-use Digital Flexible Ureteroscope (GY-UR8.4); Single-use Digital Flexible Ureteroscope (GY-UR7.5); Endoscope camera system (GY-AIO-121) | Zhejiang Geyi Medical Instrument Co., Ltd. | 2025-12-16 | Traditional | PDF ↗ |
| K251951 | Single-Use Video Flexible Ureterorenoscope (RP-U-C03R9, RP-U-C03R3, RP-U-C03S9, RP-U-C03S3); Endoscopic Video Image Processor (RP-IPD-V2000EF); Endoscopic Video Image Processor (RP-IPD-V1000F) | Guangzhou Red Pine Medical Instrument Co., Ltd. | 2025-12-16 | Traditional | PDF ↗ |
| K253411 | Miniature Telescope for Urology (27033AA) | Karl Storz SE & CO. KG | 2025-11-18 | Traditional | PDF ↗ |
| K250917 | Flexible Ureterorenoscope system (Electronic Endoscope Image Processor, model: SP-TXCLQ12.1, Flexible Ureterorenoscope, model: SP-SNGSYJ 2.0, SP-SNGSYJ 2.2, SP-SNGSYJ 2.5, SP-SNGSYJ 2.8) | Shenzhen Sanping Image Technology Co., Ltd. | 2025-10-31 | Traditional | PDF ↗ |
| K252806 | Flexible Suction Ureterorenoscope (US27G-12-EU, US27G-12-US, US33G-17-EU, US33G-17-US, US38G-20-EU, US38G-20-US.) | Shanghai AnQing Medical Instrument Co., Ltd. | 2025-10-03 | Special | PDF ↗ |
| K252703 | LithoVue Elite Single-Use Digital Flexible Ureteroscope - Standard with pressure monitoring (M0067940000); LithoVue Elite Single-Use Digital Flexible Ureteroscope - Reverse with pressure monitoring (M0067940500) | Boston Scientific Corporation | 2025-09-24 | Special | PDF ↗ |
| K250049 | Medical Video Endoscope [Standard Deflection] (URS3005); Medical Video Endoscope [Reverse Deflection] (URS3005E); Medical Video Endoscope [Standard Deflection] (URS3006); Medical Video Endoscope [Reverse Deflection] (URS3006E); Medical Video Endoscope [Standard Deflection] (URS3016); Medical Video Endoscope [Reverse Deflection] (URS3016E); Image processor (DIS8000) | Seplou (Zhuhai) Co., Ltd. | 2025-08-26 | Traditional | PDF ↗ |
| K243550 | KARL STORZ Flexible Video-Uretero-Renoscope (FLEX XC) | Karl Storz SE & CO. KG | 2025-06-06 | Traditional | PDF ↗ |
| K242699 | Flexible Ureteroscope (U-Scope)(2.8/1.2) (OMI161-2F28-CH12-US); Flexible Ureteroscope (U-Scope)(2.5/1.2) (OMI161-2F25-CH12-US); Images Systems (Camera-Controlled Unit) (OMI01M12) | Opcom Medical, Inc. | 2025-05-28 | Traditional | PDF ↗ |
| K250785 | Single-use Flexible Ureteroscope | Hunan Vathin Medical Instrument Co., Ltd. | 2025-05-06 | Traditional | PDF ↗ |
| K243894 | F88 URE-SD/RD Flexible Ureteroscope | Sg Endoscopy Pte, Ltd. | 2025-05-02 | Traditional | PDF ↗ |
| K243532 | LumiRex Ureteroscope | Contra Healthcare Solutions, LLC | 2025-04-28 | Traditional | PDF ↗ |
| K243857 | Flexible Ureterorenoscope (US27F-12-EU; US27F-12-US) | Shanghai AnQing Medical Instrument Co., Ltd. | 2025-04-11 | Traditional | PDF ↗ |
| K243708 | Urology Videoscope System (Single-use Flexible Ureteroscope: SUV-1A-B, SUV-1A-P, SUV-2A-B, SUV-2A-P, SUV-2B-B, SUB-2B-P, SUV-2C-B, SUV-2C-P;Single-use Flexible Cystoscope: SUV-1D-B, SUV-1D-P; Endoscopic Image Processor: HDVS-S100A, HDVS-S100D.) | Scivita Medical Technology Co., Ltd. | 2025-03-27 | Traditional | PDF ↗ |
| K243155 | Single-Use Digital Flexible Ureteroscope(F-URS) (ZSR-URS-01, ZSR-URS-02, ZSR-URS-03, ZSR-URS-04) | Dongguan Zsr Biomedical Technology Company Limited | 2025-02-11 | Traditional | PDF ↗ |
| K243117 | Digital Video Processor | Hunan Vathin Medical Instrument Co., Ltd. | 2025-01-29 | Traditional | PDF ↗ |
| K241956 | Single-Use Digital Flexible Ureteroscope (PUR12-1, PUR12-2, PUR12-3, PUR12-4, PUR12-5, PUR12-6, PUR12-S, PUR12-S1, PUR12-S2) | Hunan Endoso Life Technology Co., Ltd. | 2025-01-22 | Traditional | PDF ↗ |
| K240074 | Single use flexible ureteroscope (UR-D1); Single use flexible ureteroscope (UR-D2); Single use flexible ureteroscope (UR-F1); Single use flexible ureteroscope (UR-F2) | Shenzhen Besdata Technology Co., Ltd. | 2024-10-04 | Traditional | PDF ↗ |
| K241434 | Video Ureteroscope System | Hunan Vathin Medical Instrument Co., Ltd. | 2024-10-04 | Special | PDF ↗ |
| K240203 | URUS System (DMG-SU100/URUS); URUS System (DMG-SU100R/URUS); URUS System (VP-100/Video Processor) | Dyne Medical Group, Inc. | 2024-09-05 | Traditional | PDF ↗ |
| K233700 | Avicenna Roboflex | Elmed Elektronik VE Medikal Sanayi VE Ticaret Anonim Sirketi | 2024-08-16 | Traditional | PDF ↗ |
| K242108 | Ambu® aScope 5 Uretero (Standard Deflection); Ambu® aScope 5 Uretero (Reverse Deflection); Ambu® aView 2 Advance | Ambu A/S | 2024-08-16 | Special | PDF ↗ |
| K241945 | KARL STORZ Ped. Cysto-Urethro-Fiberscope (11278AC2); KARL STORZ Ped. Cysto-Urethro-Fiberscope (11278ACU1) | Karl Storz SE & CO. KG | 2024-08-01 | Special | PDF ↗ |
| K233372 | KARL STORZ Fiber Telescopes for Urology | Karl Storz SE & CO. KG | 2024-07-25 | Traditional | PDF ↗ |
| K233778 | Single Use Suction Access Ureteroscope (PU400A, PU411A), Single Use Flexible Video Ureteroscope (PU3033H, PU3033AH) | Zhuhai Pusen Medical Technology Co., Ltd. | 2024-07-16 | Traditional | PDF ↗ |
| K241639 | Single-use Video Ureterorenoscope (SVU-220US) | Huger Medical Instrument Co., Ltd. | 2024-07-01 | Special | PDF ↗ |
| K241598 | LithoVue Elite Single-Use Digital Flexible Ureteroscope - Standard (with pressure monitoring) (M0067940000); LithoVue Elite Single-Use Digital Flexible Ureteroscope - Reverse (with pressure monitoring) (M0067940500); LithoVue Elite Single-Use Digital Flexible Ureteroscope Standard (without pressure monitoring) (M0067941000); LithoVue Elite Single-Use Digital Flexible Ureteroscope Reverse (without pressure monitoring) (M0067941500) | Boston Scientific Corporation | 2024-07-01 | Special | PDF ↗ |
| K233630 | Ambu® aScope 5 Uretero (Standard Deflection); Ambu® aScope 5 Uretero (Reverse Deflection); Ambu® aBox 2 | Ambu A/S | 2024-06-24 | Traditional | PDF ↗ |
| K232911 | KARL STORZ Flexible Uretero-Reno-Fiberscope FLEX-X2S [positive deflection] (11278A2), KARL STORZ Flexible Uretero-Reno-Fiberscope FLEX-X2S [contra-positive deflection] (11278AU1) | Karl Storz Endovision, Inc. | 2024-06-10 | Traditional | PDF ↗ |
| K240374 | Ureterorenoscope System | Shenzhen HugeMed Medical Technical Development Co., Ltd. | 2024-05-10 | Traditional | PDF ↗ |
| K233275 | RenaFlex Single-use Flexible Ureteroscope (SUURF-V Standard); RenaFlex Single-use Flexible Ureteroscope (SUURF-VR Reverse); Video System Center for Single-use Endoscopes (CV-S1) | Gyrus Acmi, Inc. | 2024-03-25 | Traditional | PDF ↗ |
| K231135 | Video Ureteroscope System | Hunan Vathin Medical Instrument Co., Ltd. | 2024-01-17 | Traditional | PDF ↗ |
| K231774 | CoralView® Single-use Digital Flexible Ureteroscope (U10); CoralView® Single-use Digital Flexible Ureteroscope (U10-B); CoralView® Single-use Digital Flexible Ureteroscope (U10-BR); CoralView® Single-use Digital Flexible Ureteroscope (U20); CoralView® Single-use Digital Flexible Ureteroscope (U20-B); CoralView® Single-use Digital Flexible Ureteroscope (U20-BR) | MacroLux Medical Technology Co., Ltd. | 2024-01-11 | Traditional | PDF ↗ |
| K233645 | StoneSmart Connect Console, LithoVue Elite Standard Deflection, LithoVue Elite Reverse Deflection | Boston Scientific Corporation - | 2023-12-12 | Special | PDF ↗ |
| K230475 | Medical Video Endoscope System | Huger Medical Instrument Co., Ltd. | 2023-11-03 | Traditional | PDF ↗ |
| K223097 | RenaNav Ureteroscope System | CenterPoint Systems, LLC | 2023-07-31 | Traditional | PDF ↗ |
| K231878 | Uretero1 Single-Use Digital Flexible Ureteroscope (standard deflection), PN UROSD101, Uretero1 Single-Use Digital Flexible Ureteroscope (reverse deflection), PN URORD101, Vision1 Imaging Console and Display System, PN VIS101 | STERIS Corporation | 2023-07-25 | Special | PDF ↗ |
| K230200 | Single-Use Flexible Ureteroscope | Hunan Vathin Medical Instrument Co., Ltd. | 2023-05-18 | Traditional | PDF ↗ |
| K221158 | Single-Use Video Flexible Ureterorenoscope System | Guangzhou Red Pine Medical Instrument Co., Ltd. | 2023-03-06 | Traditional | PDF ↗ |
| K223466 | Uretero1 Single-Use Digital Flexible Ureteroscope (standard deflection), PN UROSD101; Uretero1 Single-Use Digital Flexible Ureteroscope (reverse deflection), PN URORD101; Vision1 Imaging Console and Display System, PN VIS101 | STERIS Corporation | 2023-02-17 | Special | PDF ↗ |
| K221515 | StoneSmart Connect Console, LithoVue Elite Single Use Digital Flexible Ureteroscope Standard w/Pressure Monitoring, LithoVue Elite Single Use Digital Flexible Ureteroscope Reverse w/Pressure Monitoring | Boston Scientific Corporation | 2023-02-02 | Traditional | PDF ↗ |
| K222737 | Flexible Ureterorenoscope (Model: US31E-12-EU, US31E-12-US) | Shanghai AnQing Medical Instrument Co., Ltd. | 2022-10-05 | Special | PDF ↗ |
| K220159 | Flexible Ureterorenoscope (Model: US31D-12-EU), Flexible Ureterorenoscope (Model: US31D-12-US) | Shanghai AnQing Medical Instrument Co., Ltd. | 2022-08-26 | Traditional | PDF ↗ |
| K213334 | Monarch Platform, Urology | Auris Health, Inc. | 2022-04-29 | Traditional | PDF ↗ |
| K211686 | Flexible Video-Choledo-Cysto-Ureteroscope System | Shanghai SeeGen Photoelectric Technology Co., Ltd. | 2022-02-22 | Traditional | PDF ↗ |
| K212458 | Flexible Video-Uretero-Renoscope SSU System | Karl Storz Endoscopy America | 2022-01-20 | Traditional | PDF ↗ |
| K211347 | Uretero1 Ureteroscope System | STERIS Corporation | 2021-11-23 | Traditional | PDF ↗ |
| K210579 | WiScope OM Endoscope System, WiScope Single-Use Digital Flexible Ureteroscope.Choledochoscope, WiScope Image System | OTU Medical, Inc. | 2021-07-22 | Traditional | PDF ↗ |
| K201897 | Sensor-Ureterorenoscope 9 FR WL 600 MM (short RIWO D-URS), Adapter For Controller 5525 | Richard Wolf Medical Instruments Corporation | 2021-01-15 | Traditional | PDF ↗ |
| K200369 | OES Elite Ureteroscopes and Accessories | Olympus Winter & Ibe GmbH | 2020-08-28 | Traditional | PDF ↗ |
| K201293 | Ureterorenoscope System | Shanghai AnQing Medical Instrument Co., Ltd. | 2020-07-24 | Special | PDF ↗ |
| K183188 | Flexible Sensor-Ureterorenoscopes BOA Vision EF, Flexible Sensor-Ureterorenoscopes COBRA Vision EF | Richard Wolf Medical Instruments Corporation | 2019-05-03 | Traditional | PDF ↗ |
| K181451 | URETERO-RENO VIDEOSCOPE OLYMPUS URF-V3/V3R, URETERO-RENO FIBERSCOPE OLYMPUS URF-P7/P7R | Olympus Medical Systems Corp. | 2019-01-16 | Traditional | PDF ↗ |
| K181977 | WiScope Digital Endoscope System | OTU Medical, Inc. | 2018-08-14 | Traditional | PDF ↗ |
| K180367 | Ureterorenoscope System | Shanghai AnQing Medical Instrument Co., Ltd. | 2018-07-03 | Traditional | PDF ↗ |
| K172246 | OLYMPUS URF-V2/V2R | Olympus Medical Systems Corp. | 2018-03-30 | Traditional | PDF ↗ |
| K172298 | OLYMPUS URF-P6/P6R | Olympus Medical Systems Corp. | 2018-03-29 | Traditional | PDF ↗ |
| K172098 | Medical Video Endoscope System | Zhuhai Pusen Medical Technology Co., Ltd. | 2017-08-31 | Traditional | PDF ↗ |
| K171076 | Medical Video Endoscope System | Zhuhai Pusen Medical Technology Co., Ltd. | 2017-05-05 | Traditional | PDF ↗ |
| K153049 | LithoVue System | Boston Scientific Corporation | 2015-11-13 | Traditional | PDF ↗ |
| K142556 | Flexible Video-Uretero-Choledochoscope System | KARL STORZ Endoscopy-America, Inc. | 2014-10-23 | Traditional | PDF ↗ |
| K141250 | FLEXIBLE VIDEO-URETERO-RENOSCOPE SYSTEM | KARL STORZ Endoscopy-America, Inc. | 2014-06-11 | Special | PDF ↗ |
| K131369 | FLEXIBLE VIDEO-URETERO-RENOSCOPE SYSTEM | KARL STORZ Endoscopy-America, Inc. | 2013-11-26 | Traditional | PDF ↗ |
| K121112 | STRYKER VIDEO URETEROSCOPE | Stryker Endoscopy | 2012-09-12 | Traditional | PDF ↗ |
| K111480 | MAXIFLEX - SEMI FLEX SCOPE, 25 TO 65 CM | Technology Delivery Systems, Inc. | 2012-04-04 | Traditional | PDF ↗ |
| K062707 | RUDOLF INNOVIEW AUTOCLAVABLE SEMI-RIGID URETERO-RENOSCOPE | Innovative Endoscopy Components, LLC | 2006-12-08 | Traditional | PDF ↗ |
| K062725 | MAXIFLEX-SEMI FLEX SCOPE | Technology Delivery Systems, Inc. | 2006-09-29 | Traditional | PDF ↗ |
| K052044 | ACMI AUTOCLAVABLE URETEROSCOPE, MODELS MR-6A AND MR-6AL | Acmi Corporation | 2005-08-16 | Special | PDF ↗ |
| K043021 | STRYKER URETEROSCOPE | Stryker Endoscopy | 2005-03-16 | Traditional | PDF ↗ |
| K033651 | OLYMPUS VIDEO URETEROSCOPE, NTSC | Olympus Winter & Ibe GmbH | 2004-01-30 | Special | PDF ↗ |
| K031278 | STRYKER FLEXIBLE URETEROSCOPE | Stryker Endoscopy | 2003-10-16 | Traditional | PDF ↗ |
| K023358 | USA SERIES DUR 8 ELITE, USA SERIES DUR 8, MODELS DUR 8E, DUR 8 | Acmi Corporation | 2003-01-03 | Traditional | PDF ↗ |
| K012758 | URETEROSCOPE, PEDIATRIC CYSTOURETEROSCOPE, OPERATING PEDIATRIC CYSTOURETEROSCOPE, MODELS MR-9, MR-9L, | Circon Video | 2002-04-09 | Traditional | PDF ↗ |
| K011849 | MICRO-6-SERIES (MR-6, MR-6L) URETEROSCOPES, MRO-6 SERIES (MR-633, MR-642) URETEROSCOPES, MRO-7 SERIES (MRO-733) URETEROS | Circon Video | 2001-12-10 | Traditional | PDF ↗ |
| K012951 | APN-2 USA SERIES FLEXIBLE CHOLEDOCHOSCOPE | Circon Video | 2001-11-09 | Traditional | PDF ↗ |
| K012925 | DUR-8, MODELS DUR-8 | Circon Video | 2001-11-07 | Traditional | PDF ↗ |
| K011325 | MEDIFIX URETEROSCOPE | Medifix, Inc. | 2001-07-25 | Traditional | PDF ↗ |
| K003806 | URETEROSCOPES | Global Endoscopy, Inc. | 2001-02-22 | Traditional | PDF ↗ |
| K000200 | CORTEK URETHEROSCOPE | Cortek Endoscopy, Inc. | 2000-03-03 | Traditional | PDF ↗ |
| K992527 | URETERO-RENOSCOPE | Fiber Imaging Technologies, Inc. | 1999-10-13 | Traditional | PDF ↗ |
| K991178 | FLEXIBLE FIBERSCOPE, MODEL 7331.001, GUIDE SECTION FOR LITHOVAC HANDPIECE, MODEL 8708.253 | Richard Wolf Medical Instruments Corp. | 1999-06-11 | Traditional | PDF ↗ |
| K990050 | URETERO-RENOSCOPE, MODEL 8706.402, INSERTION SHEATH, MODEL 8706.042 | Richard Wolf Medical Instruments Corp. | 1999-03-26 | Traditional | PDF ↗ |
| K982905 | MVM 7.5 FRENCH FLEXIBLE URETEROSCOPE | Karl Storz Endoscopy | 1998-10-05 | Traditional | PDF ↗ |
| K963855 | 12 URETEROSCOPES/URETERO-RENOSCOPES | Richard Wolf Medical Instruments Corp. | 1997-04-03 | Traditional | PDF ↗ |
| K970427 | KSEA URETERO-RENO-FIBERSCOPE AND NEPHRO-FIBERSCOPE | Karl Storz Endoscopy | 1997-03-11 | Traditional | PDF ↗ |
| K964482 | FLEXIBLE URETEROSCOPE | Applied Fiberoptics, Inc. | 1997-01-24 | Traditional | PDF ↗ |
| K960323 | KARL STORZ GELET URETERO-RENOSCOPES/KARL STORZ ALKEN MOTION CONTROL DEVICE | KARL STORZ Endoscopy-America, Inc. | 1996-04-22 | Traditional | PDF ↗ |
| K951855 | ULTRATHIN URETEROSCOPES | Olympus America, Inc. | 1995-08-16 | Traditional | PDF ↗ |
| K941013 | HMT ALEXCOPE | Servicetrends, Inc. | 1995-02-09 | Traditional | PDF ↗ |
| K940464 | KARL STORZ URETERO-RENOSCOPE/URETERSCOPE | KARL STORZ Endoscopy-America, Inc. | 1994-06-24 | Traditional | PDF ↗ |
| K925128 | THE KARL STORZ 11274 SERIES FLEXIBLE FIBERSCOPE | KARL STORZ Endoscopy-America, Inc. | 1993-08-18 | Traditional | PDF ↗ |
| K926423 | S/2(TM) STOPCOCK | Psi Medical Products, Inc. | 1993-03-23 | Traditional | PDF ↗ |
Product code FGB · Class II · Gastroenterology, Urology. Data: openFDA.