FDA Product Code
FDA Product Code FED — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Gastroenterology, Urology
- 21 CFR Citation
- 876.1500
510(k) Clearances — 105 records · page 1 of 2
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K260512 | Disposable Ureteral Access Sheath | Yangzhou Fartley Medical Instrument Technology Co., Ltd. | 2026-09-21 | Traditional | PDF ↗ |
| K262262 | Pathfinder Endoscope Overtube | Neptune Medical, Inc. | 2026-09-18 | Traditional | PDF ↗ |
| K260410 | Single Use Ureteral Access Sheath | Zhejiang Chuangxiang Medical Technology Co., Ltd. | 2026-09-11 | Special | PDF ↗ |
| K261915 | Navigator Flex Ureteral Access Sheath Set | Boston Scientific Corporation | 2026-08-04 | Traditional | PDF ↗ |
| K260965 | CVAC Aspiration System | Calyxo, Inc. | 2026-04-13 | Special | PDF ↗ |
| K260521 | ClearEVAC Ureteral Aspirating Access Sheath (PUS-100-1040,PUS-100-1050, PUS-100-1240,PUS-100-1250) | Zhuhai Pusen Medical Technology Co., Ltd. | 2026-04-06 | Traditional | PDF ↗ |
| K252572 | Prodeon Urethral Sheath System | Prodeon Medical, Inc. | 2025-10-07 | Traditional | PDF ↗ |
| K250128 | Single Use Suction-Evacuation Ureteral Access Sheath | Anhui Happiness Workshop Medical Instruments Co., Ltd. | 2025-09-19 | Traditional | PDF ↗ |
| K250132 | Ureteral Access Sheath | Zhejiang YiGao Medical Technology Co., Ltd. | 2025-09-05 | Traditional | PDF ↗ |
| K250695 | Single-use Ureteral Access Sheath | Shenzhen HugeMed Medical Technical Development Co., Ltd. | 2025-07-08 | Traditional | PDF ↗ |
| K251599 | Single-use Ureteral Access Sheath | Hunan Vathin Medical Instrument Co., Ltd. | 2025-07-03 | Special | PDF ↗ |
| K250585 | LumenaTM Ureteral Access Sheath | Cathegenix (Xiamen) Co., Ltd. | 2025-06-27 | Traditional | PDF ↗ |
| K250452 | CoralWell Single-use Ureteral Access Sheath (NS-0835B, NS-0840B, NS-0845B, NS-0855B, NS-0935B, NS-0940B, NS-0945B, NS-0955B, NS-1035B, NS-1040B, NS-1045B, NS-1055B, NS-1135B, NS-1140B, NS-1145B, NS-1155B, NS-1235B, NS-1240B, NS-1245B, NS-1255B, NS-1335B, NS-1340B, NS-1345B, NS-1355B, NS-1435B, NS-1440B, NS-1445B, NS-1455B) | MacroLux Medical Technology Co., Ltd. | 2025-06-02 | Traditional | PDF ↗ |
| K243710 | Disposable ureteral access sheath | Shenzhen Trious Medical Technology Co., Ltd. | 2025-04-11 | Traditional | PDF ↗ |
| K250517 | Navigator HD Ureteral Access Sheath Set 11/13 F x 28cm (M0062502210); Navigator HD Ureteral Access Sheath Set 11/13 F x 36cm (M0062502220); Navigator HD Ureteral Access Sheath Set 11/13 F x 46cm (M0062502230); Navigator HD Ureteral Access Sheath Set 12/14 F x 28cm (M0062502240); Navigator HD Ureteral Access Sheath Set 12/14 F x 36cm (M0062502250); Navigator HD Ureteral Access Sheath Set 12/14 F x 46cm (M0062502260); Navigator HD Ureteral Access Sheath Set 13/15 F x 28cm (M006 | Boston Scientific Corporation | 2025-03-21 | Special | PDF ↗ |
| K243820 | Hoover Negative Pressure Access Sheath (Hoover) (Hoover Model #'s IVX-NS-1040, IVX-NS-1050, IVX-NS-1140, IVX-NS-1150, IVX-NS-1240, IVX-NS-1250 | Dornier Medtech America | 2025-01-31 | Traditional | PDF ↗ |
| K243025 | Ureteral Access Sheath | Seplou (Zhuhai) Co., Ltd. | 2025-01-30 | Traditional | PDF ↗ |
| K242173 | Retrace Ureteral Access Sheath (ASXL10, ASXL12, ACXL10, ACXL12, AXXL10, AXXL12, ALXL10, ALXL12) | Coloplast Corp. | 2024-11-12 | Traditional | PDF ↗ |
| K243091 | Over-tube (TR-1108A) | Fujifilm Corporation | 2024-11-01 | Special | PDF ↗ |
| K240167 | Single-use Ureteral Access Sheath | Hunan Vathin Medical Instrument Co., Ltd. | 2024-10-08 | Traditional | PDF ↗ |
| K241181 | Disposable Ureteral Guide Sheath | Dongguan Zsr Biomedical Technology Company Limited | 2024-08-02 | Traditional | PDF ↗ |
| K240853 | Pathfinder® CR System | Neptune Medical, Inc. | 2024-06-27 | Traditional | PDF ↗ |
| K233472 | CVAC Aspiration System + CVAC Image Processor | Calyxo, Inc. | 2024-02-02 | Traditional | PDF ↗ |
| K230752 | Over-tube (TR-1208A); Over-tube (TR-1504A); Over-tube (TR-1507A) | FUJIFILM Healthcare Americas Corporation | 2023-09-15 | Traditional | PDF ↗ |
| K230748 | Disposable Ureteral Access Sheath | Youcare Technology Co.,Ltd. (Wuhan) | 2023-08-02 | Traditional | PDF ↗ |
| K230801 | Pathfinder Endoscope Overtube with Balloon Device | Neptune Medical, Inc. | 2023-07-28 | Traditional | PDF ↗ |
| K220065 | Single Use Ureteral Access Sheath | Zhejiang Chuangxiang Medical Technology Co., Ltd. | 2022-05-25 | Traditional | PDF ↗ |
| K200770 | Mini PCNL-System | Trokamed GmbH | 2021-07-30 | Traditional | PDF ↗ |
| K211301 | Pathfinder Endoscope Overtube | Neptune Medical, Inc. | 2021-05-28 | Special | PDF ↗ |
| K203165 | Disposable Ureteral Access Sheath | Suzhou Beyo Medical Technology Co., Ltd. | 2021-04-30 | Traditional | PDF ↗ |
| K203119 | ClearPetra Suction-Evacuation Sheath | Well Lead Medical Co., Ltd. | 2020-12-09 | Special | PDF ↗ |
| K201815 | Dornier MAGELLAN Ureteral Access Sheath | Dornier Medtech America, Inc. | 2020-11-20 | Traditional | PDF ↗ |
| K200419 | Kalera Vacuum Aspiration Catheter (K-VAC) | Kalera Medical, Inc. | 2020-05-22 | Traditional | PDF ↗ |
| K192691 | PatCom Single-Use Introducer | H&A Mui Enterprises, Inc. | 2020-02-21 | Traditional | PDF ↗ |
| K191415 | Pathfinder Endoscope Overtube | Neptune Medical, Inc. | 2019-08-30 | Traditional | PDF ↗ |
| K191067 | Arc Endocuff Glide AEG110 & AEG120 | Boddingtons Plastics, Ltd. | 2019-05-30 | Special | PDF ↗ |
| K182403 | Peel-Away Introducer | Cook Incorporated | 2019-05-29 | Traditional | PDF ↗ |
| K182520 | Flexible Overtube | Sumitomo Bakelite Co., Ltd. | 2019-05-15 | Traditional | PDF ↗ |
| K190030 | Embrella Endoscopic Distal Attachment | Micro-Tech (Nanjing) Co., Ltd. | 2019-03-05 | Traditional | PDF ↗ |
| K181811 | ReTrace Ureteral Access Sheath | Coloplast A/S | 2018-09-07 | Special | PDF ↗ |
| K173400 | ORISE Tissue Retractor System | Boston Scientific | 2018-02-09 | Traditional | PDF ↗ |
| K171208 | Trans-anal Introducer | Visionsense, Ltd. | 2018-02-05 | Traditional | PDF ↗ |
| K172575 | BAROnova Retrieval Kit, BAROnova Overtube, BAROnova Endoscope Cap | Baronova, Inc. | 2018-01-18 | Traditional | PDF ↗ |
| K172217 | Flexor Ureteral Access Sheath and Flexor Parallel Rapid Release Ureteral Access Sheath | Cook Incorporated | 2017-12-13 | Traditional | PDF ↗ |
| K162205 | Arc EndoCuff and Arc EndoCuff Vision | Boddingtons Plastics, Ltd. | 2016-12-09 | Traditional | PDF ↗ |
| K161110 | ClearPetra Suction-Evacuation Sheath | Well Lead Medical Co., Ltd. | 2016-10-12 | Traditional | PDF ↗ |
| K160846 | AmplifEYE | Medivators, Inc. | 2016-07-14 | Traditional | PDF ↗ |
| K160861 | Proxis Ureteral Access Sheath | C.R. Bard, Inc. | 2016-03-31 | Traditional | PDF ↗ |
| K151084 | Well Lead Ureteral Access Sheath | Well Lead Medical Co., Ltd. | 2016-01-07 | Traditional | PDF ↗ |
| K151801 | Arc Endocuff Vision | Boddingtons Plastics, Ltd. | 2015-08-13 | Special | PDF ↗ |
| K150083 | Sidecar External Working Channel | C2 Therapeutics | 2015-04-14 | Traditional | PDF ↗ |
| K140523 | RE-TRACE URETERAL ACCESS SHEATH, 12/14 CH/FR, LENGTH 35 CM, LENGTH 45 CM | Coloplast A/S | 2014-07-24 | Special | PDF ↗ |
| K140323 | NAVIGATOR HD URETERAL ACCESS SHEATH SETS | Boston Scientific | 2014-03-07 | Special | PDF ↗ |
| K131598 | ANAL RECTAL OVERTUBE | United States Endoscopy Group, Inc. | 2014-02-26 | Traditional | PDF ↗ |
| K133359 | ENDORINGS | Endo-Aid, Inc. | 2014-02-11 | Traditional | PDF ↗ |
| K123013 | ENDOSCOPIC INTRODUCER | Novadaq Technologies, Inc. | 2013-03-22 | Traditional | PDF ↗ |
| K123675 | RE-TRACE URETERAL ACCESS SHEATH, 10/12 FRENCH, LENGTH 35 AND 45 CM, URETERAL ACCESS SHEATH, 12/14 CH-FR, LENGTH 35CM, UR | Coloplast A/S | 2013-03-01 | Traditional | PDF ↗ |
| K122649 | NAVIGATOR HD URETERAL ACCESS SHEATH SET | Boston Scientific Corp | 2012-12-12 | Traditional | PDF ↗ |
| K122270 | OVERTUBE ENDOSCOPIC ACCESS SYSTEM | Apollo Endosurgery, Inc. | 2012-09-28 | Traditional | PDF ↗ |
| K120126 | BAROSENSE ENDOGASTRIC TUBE AND INTRODUCER BOUGIE | Barosense, Inc. | 2012-09-10 | Special | PDF ↗ |
| K122565 | ARC ENDOCUFF | Boddingtons Plastics, Ltd. | 2012-09-04 | Traditional | PDF ↗ |
| K110531 | ENDOFLIP ECD | Crospon, Ltd. | 2011-10-06 | Traditional | PDF ↗ |
| K102485 | RE-TRACE URETERAL ACCESS SHEATH | Coloplast A/S | 2010-10-18 | Traditional | PDF ↗ |
| K082102 | GASTRIC PORT, MODELS: GAP-0016-00, GAP-0018-00, GAP-0020-00 | Apollo Endosurgery, Inc. | 2010-06-14 | Traditional | PDF ↗ |
| K100081 | ENTEROSCOPY OVERTUBE, MODEL 00712140 | United States Endoscopy Group, Inc. | 2010-04-12 | Traditional | PDF ↗ |
| K092221 | COLONIC SPLINTING OVERTUBE, MODEL 00711145 | United States Endoscopy Group, Inc. | 2009-10-20 | Traditional | PDF ↗ |
| K092156 | CAD 12, COLONOSCOPY ASSIST DEVICE | Softscope Medical Technologies, Inc. | 2009-10-14 | Traditional | PDF ↗ |
| K091773 | FUJINON STERILE OVERTUBES | Fujinon, Inc. | 2009-08-07 | Special | PDF ↗ |
| K082589 | BAROSENSE ENDOGASTRIC TUBE (EGT), MODEL F0034 | Barosense, Inc. | 2009-05-22 | Traditional | PDF ↗ |
| K080050 | SPIRUS MEDICAL ENDO-EASE ENDOSCOPIC OVERTUBE | Spirus Medical, Inc. | 2008-05-06 | Traditional | PDF ↗ |
| K072405 | USGI TRANSPORT ENDOSCOPIC ACCESS DEVICE | Usgi Medical | 2007-09-13 | Special | PDF ↗ |
| K062805 | MODIFICATION TO ENDO-EASE | Spirus Medical, Inc. | 2006-10-13 | Special | PDF ↗ |
| K061324 | EMT QUIK-COVER FLEXIBLE ENDOSCOPE BARRIER SHEATH, SERIES 1-7 | Rtc Inc.-Memcath Technologies, LLC | 2006-06-20 | Traditional | PDF ↗ |
| K061216 | USGI TRANSPORT ENDOSCOPIC GUIDE | Usgi Medical | 2006-05-15 | Special | PDF ↗ |
| K052084 | ENDO-EASE ENDOSCOPIC OVERTUBE | Spirus Medical, Inc. | 2005-09-14 | Traditional | PDF ↗ |
| K051919 | MODIFICATION TO: USGI SHAPELOCK ENDOSCOPIC GUIDE | Usgi Medical | 2005-07-26 | Special | PDF ↗ |
| K051504 | SPYSCOPE ACCESS AND DELIVERY CATHETER | Boston Scientific Corp | 2005-06-16 | Traditional | PDF ↗ |
| K043418 | COOK PEDIATRIC FLEXOR URETERAL ACCESS SHEALTH | Cook Urological, Inc. | 2005-03-31 | Traditional | PDF ↗ |
| K050253 | USGI SHAPELOCK ENDOSCOPIC GUIDE | Usgi Medical | 2005-02-28 | Special | PDF ↗ |
| K040836 | DISPOSABLE OVERTUBE | United States Endoscopy Group, Inc. | 2004-06-10 | Traditional | PDF ↗ |
| K033954 | SHAPE LOCKING ENDOSCOPIC OVERTUBE | Usgi Medical, Inc. | 2004-03-19 | Traditional | PDF ↗ |
| K033778 | MODIFICATION TO BARD AQUAGUIDE URETERAL CONDUIT | C.R. Bard, Inc. | 2003-12-30 | Special | PDF ↗ |
| K023902 | SHAPE-LOCKABLE ENDOSCOPIC OVERTUBE | Usgi Medical, Inc. | 2003-08-20 | Traditional | PDF ↗ |
| K030956 | NAVIGATOR URETERAL ACCESS SHEATH SET | Boston Scientific Corp | 2003-05-23 | Special | PDF ↗ |
| K030642 | DEFLECTING URETERAL ACCESS SHEATH | Applied Medical Resources Corp. | 2003-05-23 | Traditional | PDF ↗ |
| K030438 | BARD AQUAGUIDE URETERAL CONDUIT | C.R. Bard, Inc. | 2003-03-17 | Traditional | PDF ↗ |
| K022686 | LAP SURGICAL SYSTEMS MULTIPLE INSTRUMENT GUIDE | Lap Surgical Systems, LLC | 2002-11-25 | Traditional | PDF ↗ |
| K002018 | NDO SURGICAL SURGICAL OVERTUBE | Surgical, Inc. | 2000-08-17 | Traditional | PDF ↗ |
| K993650 | URETERAL ACCESS SHEATH SET - NEW MODELS | Applied Medical Resources | 1999-12-28 | Traditional | PDF ↗ |
| K990775 | URETERAL ACCESS SHEATH SET | Applied Medical Resources | 1999-04-21 | Traditional | PDF ↗ |
| K983415 | DELIVERY SHEATH | Conway Stuart Medical, Inc. | 1998-12-01 | Traditional | PDF ↗ |
| K973500 | BARD ENDOSCOPIC OVERTUBE (#000307) | C.R. Bard, Inc. | 1997-10-16 | Traditional | PDF ↗ |
| K972781 | OT-1 | Prism Therapeutics, LLC | 1997-09-19 | Traditional | PDF ↗ |
| K942573 | COSTELLO-EVERETT LASER CYSTOSCOPE SHEATH | Richard Hamer Assoc., Inc. | 1994-07-18 | Traditional | PDF ↗ |
| K942044 | BARD ENDOSCOPIC OVERTUBE | C.R. Bard, Inc. | 1994-06-10 | Traditional | PDF ↗ |
| K921120 | FLEXIBLE CYSTOSCOPY INTRODUCING CATHETER | Cook Urological, Inc. | 1992-08-04 | Traditional | PDF ↗ |
| K912265 | MEDILASE SEMI-RIGID INSTROD SHEATH SERIES AE1000 | Medical Laser, Inc. | 1991-10-10 | Traditional | PDF ↗ |
| K903842 | ST-E1 OVERTUBE | Olympus Corp. | 1991-01-23 | Traditional | PDF ↗ |
| K896680 | PROBE SHEATH FOR ADMS & CAPISTRANO LABS TRANSREC. | Interson Corp. | 1990-02-14 | Traditional | PDF ↗ |
| K890629 | ESOPHAGEAL OVERTUBE | Gastrotech, Inc. | 1989-05-31 | Traditional | PDF ↗ |
Product code FED · Class II · Gastroenterology, Urology. Data: openFDA.