FDA Product Code
FDA Product Code EOQ — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Ear, Nose, Throat
- 21 CFR Citation
- 874.4680
510(k) Clearances — 244 records · page 1 of 3
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K261637 | Single-use Flexible Bronchoscope | Hunan Vathin Medical Instrument Co., Ltd. | 2026-09-23 | Traditional | PDF ↗ |
| K260309 | Ambu® aScope 5 Broncho 2.7/1.2; Ambu® aScope 5 Broncho 4.2/2.2; Ambu® aScope 5 Broncho 4.2/2.2 Sampler Set | Ambu A/S | 2026-09-16 | Traditional | PDF ↗ |
| K254026 | 3.8mm Slim ProVu Video Bronchoscope (090-02-0038U); 5.0mm Regular ProVu Video Bronchoscope (090-02-0050U); 6.0mm Large ProVu Video Bronchoscope (090-02-0060U); ProVu Video Bronchoscope 8 display (040-07-0082U) | Flexicare Medical Limited. | 2026-09-02 | Traditional | PDF ↗ |
| K260382 | MONARCH Platform (MON-000008) | Auris Health, Inc. | 2026-07-25 | Traditional | PDF ↗ |
| K254037 | LungFlow Airway Catheter | Free Flow Medical, Inc. | 2026-07-10 | Traditional | PDF ↗ |
| K253137 | FUJIFILM Endoscope Model EB-840S; FUJIFILM Endoscope Model EB-840T | Fujifilm Corporation | 2026-06-16 | Traditional | PDF ↗ |
| K260565 | SmartClip Delivery Catheter (ADR-1715) | Elucent Medical | 2026-05-14 | Traditional | PDF ↗ |
| K252341 | EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-Q190); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-H190 ); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-1TH190) | Olympus Medical Systems Corp. | 2026-04-23 | Traditional | PDF ↗ |
| K260420 | LoopView® Single-Use Digital Flexible Bronchoscope (B27-C, B27-CG) | MacroLux Medical Technology Co., Ltd. | 2026-04-08 | Traditional | PDF ↗ |
| K250863 | FUJIFILM Ultrasonic Endoscope EB-710US | Fujifilm Corporation | 2025-12-12 | Traditional | PDF ↗ |
| K251731 | KARL STORZ Flexible Intubation Video Endoscope Sterile (FIVE-S) (0916612) | Karl Storz SE & CO. KG | 2025-12-05 | Special | PDF ↗ |
| K252045 | Ion Endoluminal System (IF1000) | Intuitive Surgical, Inc. | 2025-09-23 | Traditional | PDF ↗ |
| K251894 | Himaging Bronchscope System | Himaging Technology (Shanghai) Co., Ltd. | 2025-09-23 | Traditional | PDF ↗ |
| K252528 | Ion Endoluminal System (IF1000) | Intuitive Surgical, Inc. | 2025-09-05 | Special | PDF ↗ |
| K251752 | Flexible Bronchoscope (BS27U-12EU, BS27U-12US, BS38U-20EU, BS38U-20US) | Shanghai AnQing Medical Instrument Co., Ltd. | 2025-08-27 | Traditional | PDF ↗ |
| K251823 | UE BRONCHO Single-Use Bronchoscopes (EBS-380C); UE BRONCHO Single-Use Bronchoscopes (EBS-500C); UE BRONCHO Single-Use Bronchoscopes (EBS-600C); UE Display (UE-M10S) | Zhejiang UE Medical Corp. | 2025-08-11 | Traditional | PDF ↗ |
| K250232 | Vathin® Video Bronchoscope System | Hunan Vathin Medical Instrument Co., Ltd. | 2025-07-25 | Traditional | PDF ↗ |
| K250862 | EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-XP190); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-P190); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-XT190); BRONCHOVIDEOSCOPE (OLYMPUS BF-H1100); BRONCHOVIDEOSCOPE (OLYMPUS BF-1TH1100) | Olympus Medical Systems Corp. | 2025-06-23 | Traditional | PDF ↗ |
| K244017 | FUJIFILM Endoscope Model EB-710P; FUJIFILM Processor EP-8000 | Fujifilm Corporation | 2025-06-13 | Traditional | PDF ↗ |
| K250118 | Disposable Balloon Catheter B5-2C | Olympus Medical Systems Corporation | 2025-06-04 | Traditional | PDF ↗ |
| K250957 | Disposable Biopsy Forceps (FB-211D); Disposable Biopsy Forceps (FB-221D); Disposable Biopsy Forceps (FB-231D); Disposable Biopsy Forceps (FB-241D) | Olympus Medical Systems Corporation | 2025-05-30 | Traditional | PDF ↗ |
| K243497 | Portable Video Processor (EA101), Flexible Bronchoscope BS41H-12EU, BS41H-12US, BS46H-17EU, BS50H-20EU, BS46H-17US, BS50H-20US, BS53H-22EU, BS53H-22US, BS55H-24EU, BS55H-24US, BS59H-28EU, BS59H-28US | Shanghai AnQing Medical Instrument Co., Ltd. | 2025-05-29 | Traditional | PDF ↗ |
| K242793 | Insighters Single-use Bronchoscope/Insight Bimodel-Integral iS-B12A 4.6/2.0; Insighters Single-use Bronchoscope/Insight Bimodel-Integral iS-B22A 5.5 /2.6; Insighters Single-use Bronchoscope/Insight Bimodel-Integral iS-B26A 6.0/3.0; Insighters Insight Workstation iS-PF1. | Shenzhen Insighters Medical Technology Co., Ltd. | 2025-05-28 | Traditional | PDF ↗ |
| K243541 | LumiRex Bronchoscope | Contra Healthcare Solutions, LLC | 2025-04-30 | Traditional | PDF ↗ |
| K250210 | Broncho Videoscope System (Single-use Broncho Videoscope (SBV-1A-B, SBV-1A-P, SBV-1B-B, SBV-1B-P, SBV-1C-B, SBV-1C-P); Full HD Visualization Endoscopic Image Processor (HDVS-S300A, HDVS-S300B, HDVS-S300C, HDVS-S300D); Endoscopic Image Processor (HDVS-S100A, HDVS-S100D)) | Scivita Medical Technology Co., Ltd. | 2025-03-19 | Special | PDF ↗ |
| K242010 | Bronchoscope System, The Single-use Bronchoscope (Single-use Bronchoscope: SP-Y-ZQGJ2.8, SP-Y-ZQGJ3.8, SP-Y-ZQGJ4.2, SP-Y-ZQGJ4.8, SP-Y-ZQGJ5.2, SP-Y-ZQGJ5.8; Electronic Endoscope Imaging Processor: SP-TXCLQ12.1) | Shenzhen Sanping Image Technology Co., Ltd. | 2025-03-14 | Traditional | PDF ↗ |
| K242324 | DUTAU-NOVATECH® | Novatech SA | 2025-02-06 | Traditional | PDF ↗ |
| K243219 | MONARCH Platform (MON-000008) | Auris Health, Inc. | 2025-01-23 | Traditional | PDF ↗ |
| K242416 | Single-use Flexible Bronchoscope: BC-E1C10, BC-E1C11, BC-E1C12, BC-E1E10, BC-E1E11, BC-E1E12, BC-E1H10, BC-E1H11, BC-E1H12; Digital Video Monitor: DVM-D1, DVM-D2; Single-use sampler: S-20mL, S-30mL, S-50mL | Hunan Vathin Medical Instrument Co., Ltd. | 2025-01-16 | Traditional | PDF ↗ |
| K241612 | Video Bronchoscope System; Single-use Flexible Bronchoscope (BC-S1E00-L, BC-S1H00-L, BC-S1J00-L, BC-S1E00, BC-S1H00, BC-S1J00.); Digital Video Monitor (DVM-D1, DVM-D2) | Hunan Vathin Medical Instrument Co., Ltd. | 2024-10-29 | Traditional | PDF ↗ |
| K240289 | Full HD Endoscopic Image Processor (HDVS-S200A, HDVS-S200B, HDVS-S200C, HDVS-S200D) | Scivita Medical Technology Co., Ltd. | 2024-10-23 | Traditional | PDF ↗ |
| K242070 | Ion Endoluminal System (IF 1000) | Intuitive Surgical, Inc. | 2024-09-24 | Traditional | PDF ↗ |
| K232601 | BroncTru Transbronchial Access Tool | Broncus Medical, Inc. | 2024-05-31 | Traditional | PDF ↗ |
| K234113 | MiiS Horus Bronchoscope; MiiS Horus Endoscope Display System -Tablet; MiiS Horus Endoscope Display System -Video Box | Medimaging Integrated Solution, Inc (Miis) | 2024-05-01 | Traditional | PDF ↗ |
| K232038 | BioStar Single Use Transbronchial Aspiration Needle | Broncus Medical, Inc. | 2024-04-26 | Traditional | PDF ↗ |
| K233779 | LoopView® Single-Use Digital Flexible Bronchoscope (B38, B38-C, B50, B50-C, B58, B58-C), ViewHub® Video Processor (S13) | MacroLux Medical Technology Co., Ltd. | 2024-04-05 | Traditional | PDF ↗ |
| K240135 | Ion Endoluminal System (Ion Fully Articulating Catheter) (IF1000) | Intuitive Surgical, Inc. | 2024-04-03 | Traditional | PDF ↗ |
| K231107 | Bronchoscope System | Hunan Endoso Life Technology Co., Ltd. | 2024-02-15 | Traditional | PDF ↗ |
| K240075 | FUJIFILM Endoscope Model EB-710XT | FUJIFILM Healthcare Americas Corporation | 2024-02-07 | Special | PDF ↗ |
| K232860 | PENTAX Medical Video Processor EPK-i8020c, PENTAX Medical Video Bronchoscope EB11-J10, PENTAX Medical Video Bronchoscope EB15-J10, PENTAX Medical Video Bronchoscope EB19-J10U, PENTAX Medical Ultrasound Video Bronchoscope EB19-J10U | Pentax of America, Inc. | 2024-01-18 | Traditional | PDF ↗ |
| K231970 | PENTAX Medical Single Use Video Bronchoscope EB11-S01, PENTAX Medical Single Use Video Bronchoscope EB15-S01, PENTAX Medical Mobile Processor ONE-M, PENTAX Medical Mobile Processor Plug-In ONE-Dock | Pentax of America, Inc. | 2024-01-12 | Traditional | PDF ↗ |
| K233671 | Ambu® aScope 5 Broncho 4.2/2.2; Ambu® aScope 5 Broncho 2.7/1.2; Ambu® aView 2 Advance | Ambu A/S | 2024-01-04 | Special | PDF ↗ |
| K232984 | Ion Endoluminal System (IF1000) | Intuitive Surgical, Inc. | 2023-12-18 | Traditional | PDF ↗ |
| K231521 | Broncho Videoscope System | Scivita Medical Technology Co., Ltd. | 2023-11-14 | Traditional | PDF ↗ |
| K232582 | Ambu® aScope 5 Broncho 4.2/2.2 Sampler Set | Ambu A/S | 2023-09-20 | Special | PDF ↗ |
| K230428 | Ambu® aScope 5 Broncho 2.7/1.2, Ambu® aScope 5 Broncho 4.2/2.2, Ambu® aBox 2 | Ambu A/S | 2023-08-10 | Traditional | PDF ↗ |
| K222861 | EVIS XI Video System Center Olympus CV-1500, Bronchovideoscope Olympus BF-H1100, Bronchovideoscope Olympus BF-1TH1100 | Olympus Medical Systems Corporation | 2023-06-15 | Traditional | PDF ↗ |
| K223299 | Ambu® aScope 5 Broncho HD 5.0/2.2, Ambu® aScope 5 Broncho HD 5.6/2.8, Ambu® aView 2 Advance | Ambu A/S | 2023-06-01 | Traditional | PDF ↗ |
| K223836 | Vathin® Video Bronchoscope System | Hunan Vathin Medical Instrument Co., Ltd. | 2023-05-15 | Traditional | PDF ↗ |
| K230948 | BFlex 2 Slim 3.8 Single-Use Bronchoscope | Verathon Medical (Canada) Ulc | 2023-05-03 | Special | PDF ↗ |
| K222910 | Bronchoscope System | Shenzhen HugeMed Medical Technical Development Co., Ltd. | 2023-04-11 | Traditional | PDF ↗ |
| K221340 | iNod Ultrasound Guided Biopsy Needle (UPN: M00502060), iNod Ultrasound Guidance Console (UPN: M00503210) | Boston Scientific Corporation | 2023-03-02 | Traditional | PDF ↗ |
| K223144 | Galaxy System | Noah Medical Corp. | 2023-03-01 | Traditional | PDF ↗ |
| K223782 | Ambu aScope 5 Broncho HD 5.6/2.8 Sampler Set, Ambu aScope 5 Broncho HD 5.0/2.2 Sampler Set | Ambu A/S | 2023-01-12 | Special | PDF ↗ |
| K213235 | PENTAX Medical ONE Pulmo Single Use Video Bronchoscope System | Pentax of America, Inc. | 2022-12-21 | Traditional | PDF ↗ |
| K220957 | FUJIFILM Endoscope Model EB-710P | Fujifilm Corporaton | 2022-11-10 | Traditional | PDF ↗ |
| K221631 | Tracheal Intubation Fiberscope OLYMPUS LF-P, VISERA Tracheal Intubation Videoscope OLYMPUS LF Type V | Olympus Medical Systems Corp. | 2022-09-26 | Traditional | PDF ↗ |
| K221302 | Recon Steerable Sheath | Serpex Medical, Inc. | 2022-08-15 | Traditional | PDF ↗ |
| K222014 | EXALT Model B Single-Use Bronchoscope | Boston Scientific Corporation | 2022-07-28 | Special | PDF ↗ |
| K220606 | Ambu aScope 5 Broncho HD 5.6/2.8, Ambu aScope 5 Broncho HD 5.0/2.2, Ambu aBox 2 | Ambu A/S | 2022-07-25 | Traditional | PDF ↗ |
| K213782 | Single-Use Video Bronchoscopes, Digital Controller | Micro-Tech (Nanjing) Co., Lts | 2022-07-08 | Traditional | PDF ↗ |
| K220399 | WiScope Digital Bronchoscope System, WiScope Single-Use Digital Flexible Bronchoscope, WiScope Image System | OTU Medical, Inc. | 2022-06-16 | Traditional | PDF ↗ |
| K220299 | Ion Endoluminal System (IF1000) | Intuitive Surgical, Inc. | 2022-06-16 | Traditional | PDF ↗ |
| K213635 | Vathin Video Bronchoscope System | Hunan Vathin Medical Instrument Co., Ltd. | 2022-02-28 | Traditional | PDF ↗ |
| K212886 | Broncoflex Agile, Broncoflex Vortex, Screeni | Axess Vision Technology | 2022-02-16 | Traditional | PDF ↗ |
| K212656 | Flexible Intubation Video Endoscope Sterile (FIVE-S) | Karl Storz Endoscopy America | 2021-12-29 | Special | PDF ↗ |
| K211169 | Bronchoscope System | Shanghai AnQing Medical Instrument Co., Ltd. | 2021-11-24 | Traditional | PDF ↗ |
| K211947 | GlideScope BFlex 2.8 Single-Use Bronchoscope | Verathon Medical (Canada) Ulc | 2021-11-03 | Traditional | PDF ↗ |
| K210928 | PENTAX Medical Video Bronchoscope EB11-J10 | Pentax of America, Inc. | 2021-10-21 | Traditional | PDF ↗ |
| K212667 | Single Use Guide Sheath Kit-401, K-402 | Olympus Medical Systems Corp. | 2021-09-22 | Special | PDF ↗ |
| K212048 | Ion Endoluminal System (Ion Fully Articulating Catheter), Ion Endoluminal System (Ion Peripheral Vision Probe) | Intuitive Surgical, Inc. | 2021-08-26 | Traditional | PDF ↗ |
| K211030 | EXALT Model B Single-Use Bronchoscope (Slim), EXALT Model B Single-Use Bronchoscope (Regular), EXALT Model B Single-Use Bronchoscope (Large), EXALT Monitor | Boston Scientific Corporation | 2021-08-09 | Traditional | PDF ↗ |
| K210379 | Broncho Videoscope System | Scivita Medical Technology Co., Ltd. | 2021-07-28 | Traditional | PDF ↗ |
| K211493 | Monarch Platform | Auris Health, Inc. | 2021-07-09 | Special | PDF ↗ |
| K210883 | aScope 4 Broncho Regular Sampler Set 5.0/2.2, aScope 4 Broncho Large Sampler Set 5.8/2.8 | Ambu A/S | 2021-06-17 | Special | PDF ↗ |
| K202987 | Rescue Pulmonary Grasping Forceps | Anrei Medical (Hangzhou) Co., Ltd. | 2021-04-29 | Traditional | PDF ↗ |
| K202346 | SPiN Vision Video Bronchoscope System | Veran Medical Technologies, Inc. | 2021-02-19 | Traditional | PDF ↗ |
| K201300 | Airway Mobilescope | Olympus Medical Systems Corp. | 2021-01-26 | Traditional | PDF ↗ |
| K201758 | EVIS EXERA III Bronchovideoscope Olympus BF-XP190, EVIS EXERA III Bronchovideoscope Olympus BF-P190 | Olympus Medical Systems Corp. | 2021-01-21 | Traditional | PDF ↗ |
| K200702 | EasyPath RF Introducer Sheath | Broncus Medical, Inc. | 2021-01-14 | Traditional | PDF ↗ |
| K200342 | Single Use Grasping Forceps FG-214P, Single Use Grasping Forceps FG-220P, Single Use Grasping Forceps FG-226C, Single Use Grasping Forceps FG-232L, Single Use Grasping Forceps FG-804L | Olympus Medical Systems Corp. | 2020-12-17 | Traditional | PDF ↗ |
| K202370 | Ion Endoluminal System | Intuitive Surgical, Inc. | 2020-11-16 | Traditional | PDF ↗ |
| K202180 | Broncoflex Agile; Product Reference: 20030001 , Broncoflex Vortex; Product Reference: 10030001, Screeni; Product Reference: 30030001 | Axess Vision Technology | 2020-10-22 | Traditional | PDF ↗ |
| K200678 | PENTAX Medical Video Bronchoscope EB-J10 Series | Pentax of America, Inc. | 2020-07-30 | Traditional | PDF ↗ |
| K201146 | Ion Endoluminal System | Intuitive Surgical, Inc. | 2020-06-26 | Traditional | PDF ↗ |
| K200397 | Single Use Biopsy Forceps FB-456D | Olympus Medical Systems Corp. | 2020-04-24 | Traditional | PDF ↗ |
| K193534 | Monarch Platform | Auris Health, Inc. | 2020-04-15 | Traditional | PDF ↗ |
| K192164 | Single Use Guide Sheath Kit K-401, K-402, & Single Use Guiding Device CC-220DR | Olympus Medical Systems Corp. | 2020-03-06 | Traditional | PDF ↗ |
| K191828 | Vathin Video Bronchoscope System | Hunan Vathin Medical Instrument Co., Ltd. | 2020-02-13 | Traditional | PDF ↗ |
| K193488 | GlideScope BFlex 3.8 Single-Use Bronchoscope | Verathon Medical (Canada) Ulc | 2020-01-16 | Special | PDF ↗ |
| K192367 | Ion Endoluminal System | Intuitive Surgical, Inc. | 2019-11-26 | Traditional | PDF ↗ |
| K183516 | PENTAX Medical Ultrasound Video Bronchoscope EB19-J10U | Pentax of America, Inc. | 2019-09-06 | Traditional | PDF ↗ |
| K183419 | EVIS EXERA III Bronchovideoscope Olympus BF-XT190 | Olympus Medical Systems Corp. | 2019-09-05 | Traditional | PDF ↗ |
| K183607 | FUJIFILM Bronchoscope | Fujifilm Corporation | 2019-08-23 | Traditional | PDF ↗ |
| K191948 | GlideScope BFlex 5.8 Single-Use Bronchoscope | Verathon Medical (Canada) Ulc | 2019-08-21 | Special | PDF ↗ |
| K183654 | PENTAX Medical EB-1970UK Ultrasound Video Bronchoscope + Hitachi NOBLUS and HI VISION Preirus | Pentax of America, Inc. | 2019-05-23 | Special | PDF ↗ |
| K182253 | FUJIFILM Video Bronchoscopes | Fujifilm Corporation | 2019-04-04 | Traditional | PDF ↗ |
| K183085 | CoreDx Pulmonary Mini-Forceps | Boston Scientific Corporation | 2019-03-08 | Traditional | PDF ↗ |
| K182825 | FUJIFILM Ultrasonic Endoscope | Fujifilm Corporation | 2019-02-22 | Special | PDF ↗ |
| K182188 | Ion Endoluminal System ; Flexision Biopsy Needle | Intuitive Surgical | 2019-02-14 | Traditional | PDF ↗ |
Product code EOQ · Class II · Ear, Nose, Throat. Data: openFDA.