FDA Product Code
FDA Product Code FGE — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Gastroenterology, Urology
- 21 CFR Citation
- 876.5010
510(k) Clearances — 478 records · page 1 of 5
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K254179 | Drainage Catheter | Canyon Medical, Inc. | 2026-09-18 | Traditional | PDF ↗ |
| K262913 | Protégé EverFlex Self-expanding Peripheral Stent System | Medtronic, Inc. | 2026-09-17 | Special | PDF ↗ |
| K260835 | ARCHIMEDES Biodegradable Stent (Medium) | Q3 Medical USA, LLC (C/O Q3 Medical Devices Ltd.) | 2026-07-27 | Traditional | PDF ↗ |
| K253393 | Single-use Balloon Dilatation Catheter (AG-5251-083018 AG-5251-085518 AG-5251-088018 AG-5251-083019 AG-5251-085519 AG-5251-088019 AG-5251-083021 AG-5251-085521 AG-5251-088021 AG-5251-083024 AG-5251-085524 AG-5251-088024 AG-5251-103018 AG-5251-105518 AG-5251-108018 AG-5251-103019 AG-5251-105519 AG-5251-108019 AG-5251-103021 AG-5251-105521 AG-5251-108021 AG-5251-103024 AG-5251-105524 AG-5251-108024 AG-5251-123018 AG-5251-125518 AG-5251-128018 AG-5251-123019 AG-5251-125519 AG-5251-128019 | Hangzhou AGS MedTech Co., Ltd. | 2026-06-24 | Traditional | PDF ↗ |
| K253832 | Dilation Balloon Catheter | Mirco-Tech (Nanjing) Co., Ltd. | 2026-04-24 | Traditional | PDF ↗ |
| K251658 | Endoflux Biliary & Pancreatic Stent Sets | Medi-Globe GmbH | 2026-04-16 | Traditional | PDF ↗ |
| K253987 | BARE Wireguided Balloon Dilation Catheter (1235) | GIE Medical | 2026-03-13 | Traditional | PDF ↗ |
| K253132 | Single use stone retrieval balloons | Zhejiang Chuangxiang Medical Technology Co., Ltd. | 2026-03-06 | Traditional | PDF ↗ |
| K251123 | Niti-S Biliary Stent; Niti-S Biliary Slim M Stent | Taewoong Medical Co., Ltd. | 2025-12-29 | Traditional | PDF ↗ |
| K251019 | BIOTEQ Drainage Catheter Set: BT-PD1-SERIES-G and BT-PDS-SERIES-G | Bioteque Corporation | 2025-12-22 | Traditional | PDF ↗ |
| K250409 | Disposable Balloon Catheter (B5-2Q); Disposable Balloon Catheter (B7-2Q); Disposable Balloon Catheter (B7-2LA) | Olympus Medical Systems Corporation | 2025-10-21 | Traditional | PDF ↗ |
| K251229 | EndoFixTissue Fixation System | Softac Medical Technologies | 2025-08-20 | Traditional | PDF ↗ |
| K243412 | ARCHIMEDES Biodegradable Pancreatic Stent | Q3 Medical USA, LLC (C/O Q3 Medical Devices Ltd.) | 2025-07-16 | Traditional | PDF ↗ |
| K251291 | Advanix Pancreatic Stent and NaviFlex Rapid Exchange (RX) Pancreatic Delivery System and Pushers | Boston Scientific | 2025-07-03 | Traditional | PDF ↗ |
| K242845 | EGIS Biliary Double Bare Stent (BDB080405) | S&G Biotech, Inc. | 2025-06-25 | Traditional | PDF ↗ |
| K241888 | Single-use Balloon Dilatation Catheter | Leo Medical Co., Ltd. | 2024-12-20 | Traditional | PDF ↗ |
| K241801 | Tornus ES | Asahi Intecc Co., Ltd. | 2024-12-17 | Traditional | PDF ↗ |
| K242950 | WallFlex Biliary PLUS RX Stent System | Boston Scientific | 2024-12-06 | Traditional | PDF ↗ |
| K240464 | WallFlex Biliary RX Stent System; Epic Biliary Stent System; WallFlex Biliary RX Fully Covered Stent System RMV | Boston Scientific | 2024-08-30 | Traditional | PDF ↗ |
| K233079 | Zimmon® Pancreatic Stents/Stent sets (SPSOF, SPSOS, ZEPDF, ZEPDS, ZPSOF, ZPSOS); Geenen® Pancreatic Stents/Stent Sets (GEPD, GPDS, GPSO, GPSOS); Johlin® Pancreatic Wedge Stent and Introducer Set (JPWS); Pushing Catheter and Guiding Catheter (GC, PC); Geenen® Sof-Flex® Pancreatic Stent (GPSO-SF. GPSOS-SF) | Cook Ireland, Ltd. | 2024-06-14 | Traditional | PDF ↗ |
| K232245 | VedDilator ^TM (3-Stage Balloon Dilation Catheter) | Jiangsu Vedkang Medical Science and Technology Co., Ltd. | 2024-02-15 | Traditional | PDF ↗ |
| K232596 | EndoGI S-Path Biliary Stent System | Endogi Medical, Ltd. | 2023-09-27 | Special | PDF ↗ |
| K223354 | EGIS Biliary Single Bare Stent | S&G Biotech, Inc. | 2023-09-21 | Traditional | PDF ↗ |
| K230127 | Biliary Plastic Stent, Biliary Plastic Stent Introducer, Biliary Plastic Stent Set, Biliary Plastic Stent Introducer/ short-wire compatible, Biliary Plastic Stent Set/ short-wire compatible | Micro-Tech (Nanjing) Co., Ltd. | 2023-09-06 | Traditional | PDF ↗ |
| K223469 | WallFlex Biliary RX Stent System | Boston Scientific Corporation | 2023-06-15 | Traditional | PDF ↗ |
| K223626 | Niti-S Biliary Speed D Stent | Taewoong Medical Co., Ltd. | 2023-05-26 | Traditional | PDF ↗ |
| K222663 | MultiStage Balloon Dilatation Catheter | Dongguan TT Medical, Inc. | 2023-03-09 | Traditional | PDF ↗ |
| K223592 | Advanix Pancreatic Stent and NaviFlex Rapid Exchange (RX) Pancreatic Delivery System and Pushers | Boston Scientific Corporation | 2022-12-29 | Special | PDF ↗ |
| K222627 | EndoGI S-Path Biliary Stent System | Endo GI Medical | 2022-09-28 | Special | PDF ↗ |
| K221071 | Niti-S Biliary Slim M Stent | Taewoong Medical Co., Ltd. | 2022-06-09 | Traditional | PDF ↗ |
| K213946 | Compass BDS Biliary Stent | Cook Ireland, Ltd. | 2022-05-09 | Traditional | PDF ↗ |
| K211021 | Sterile Biliary Stone Retrieval Balloon Catheter, Retrieval Balloon / short-wire compatible | Micro-Tech (Nanjing) Co., Ltd. | 2022-05-06 | Traditional | PDF ↗ |
| K210419 | BIOTEQ Drainage Catheter BT-PDS-series | Bioteque Corporation | 2022-04-13 | Traditional | PDF ↗ |
| K202973 | HANAROSTENT Benefit Biliary (NNN) | M.I.Tech Co., Ltd. | 2021-05-11 | Traditional | PDF ↗ |
| K203162 | Advanix Biliary Stent with NaviFlex RX Delivery System | Boston Scientific Corporation | 2020-12-18 | Traditional | PDF ↗ |
| K200103 | BIOTEQ Drainage Catheter Set (One Step Type) | Bioteque Corporation | 2020-10-09 | Traditional | PDF ↗ |
| K202477 | EndoGI S-Path Biliary Stent System | Endo GI Medical | 2020-09-24 | Special | PDF ↗ |
| K193600 | EndoGI Biliary Stent System | Endogi Medical, Ltd. | 2020-06-26 | Traditional | PDF ↗ |
| K181669 | ConvertX Biliary Stent System | Brightwater Medical | 2019-03-14 | Traditional | PDF ↗ |
| K183396 | HANAROSTENT FASTTM Biliary (NNN) | M.I.Tech Co., Ltd. | 2019-02-11 | Traditional | PDF ↗ |
| K182980 | Zilver 518 Biliary Stent, Zilver 635 Biliary Stent | Cook Ireland, Ltd. | 2018-11-16 | Special | PDF ↗ |
| K180418 | Reliant(TM) Multistage Dilatation Balloon Catheter | Micro-Tech (Nanjing) Co., Ltd. | 2018-10-15 | Traditional | PDF ↗ |
| K180868 | Nasal Biliary Drainage Set, Liguory Nasal Biliary Drainage Set, Nagaraja Nasal Biliary Drainage Set, Leung Nasal Biliary Drainage Set | Cook Ireland | 2018-07-06 | Traditional | PDF ↗ |
| K173035 | Gordon Large-Bore Curved Drainage Catheter, Nephrostomy Pigtail Drainage Catheter, Percutaneous Nephrostomy Set, Pigtail Drainage Catheter Needle Set, Multipurpose Drainage Catheters and Sets | Cook Incorporated | 2018-05-01 | Traditional | PDF ↗ |
| K172057 | Zimmon Pancreatic Stents/Stent sets, Geenen Pancreatic Stents/Stent Sets, Pushing Catheter and Guiding Catheter, Johlin Pancreatic Wedge Stent and Introducer Set | Cook Ireland, Ltd. | 2018-03-09 | Traditional | PDF ↗ |
| K180086 | Gyrus ACMI EZDilate 3-Stage Balloon Dilatation Catheter | Gyrus Acmi, Inc. | 2018-03-08 | Traditional | PDF ↗ |
| K172044 | Cotton-Huibregtse Stent, Cotton-Leung Biliary Stent, Cotton-Leung Sof-Flex Biliary Stent, Soehendra Tannenbaum Biliary Stent, Zimmon Biliary Stent, Guiding Catheter, Pushing catheter, Fusion pushing catheter, Stent Introducer Set, Fusion Oasis One Action Sent Introduction System, Zimmon Biliary Stent Set, Oasis One Action Stent Introduction System, Solus Double Pigtail Stent and Introduction System, Cotton-Huibregtse Biliary Stent Set, Cotton-Leung Biliary Stent Set, Oasis One Action S | Cook Ireland, Ltd. | 2018-02-27 | Traditional | PDF ↗ |
| K171548 | Cotton Graduated Dilation Catheter, Fusion Biliary Dilation Catheter, Soehendra Biliary Dilation Catheter, Geenen Graduated Dilation Catheter | Wilson-Cook Medical, Inc. | 2017-10-13 | Traditional | PDF ↗ |
| K172520 | CRE RX Biliary Balloon Dilatation Catheter | Boston Scientific Corporation | 2017-10-04 | Traditional | PDF ↗ |
| K171809 | Epic Biliary Endoscopic Stent System | Boston Scientific Corporation | 2017-08-09 | Traditional | PDF ↗ |
| K171623 | Nasal Pancreatic Drainage Set | Cook Ireland, Ltd. | 2017-07-31 | Traditional | PDF ↗ |
| K171223 | Quantum TTC Biliary Balloon Dilator | Wilson-Cook Medical, Inc. | 2017-06-16 | Traditional | PDF ↗ |
| K170740 | GORE VIABIL Short Wire Biliary Endoprosthesis | W. L. Gore & Associates, Inc. | 2017-05-08 | Traditional | PDF ↗ |
| K170743 | AngioDynamics Total Abscession Biliary Drainage Catheter | AngioDynamics, Inc. | 2017-03-30 | Special | PDF ↗ |
| K163169 | Zilver 518TM Biliary Stent; Zilver 635TM Biliary Stent | Cook Ireland, Ltd. | 2017-02-07 | Traditional | PDF ↗ |
| K162226 | Reliant Multistage Dilatation Balloon Catheter | Micro-Tech (Nanjing) Co., Ltd. | 2017-01-25 | Traditional | PDF ↗ |
| K163018 | Zilver 635 Biliary Stent | Cook Ireland, Ltd. | 2016-12-23 | Traditional | PDF ↗ |
| K162404 | Express SD Biliary Monorail Premounted Stent System | Boston Scientific Corporation | 2016-10-12 | Traditional | PDF ↗ |
| K161203 | Soehendra Stent Retriever | Wilson-Cook Medical, Inc. | 2016-05-04 | Special | PDF ↗ |
| K150487 | X-Suit NIR Biliary Metallic Stent | Medinol, Ltd. | 2016-02-12 | Traditional | PDF ↗ |
| K152853 | WALLSTENT RP Endoprosthesis Transhepatic Biliary, WALLSTENT Endoprosthesis Transhepatic Biliary | Boston Scientific Corp | 2015-11-20 | Traditional | PDF ↗ |
| K151925 | Elation Wireguided Balloon Dilation Catheter | Merit Medical Systems, Inc. | 2015-11-06 | Traditional | PDF ↗ |
| K152607 | Express SD Biliary Monorail Premounted Stent System | Boston Scientific | 2015-10-27 | Traditional | PDF ↗ |
| K151671 | Disposable Multistage Dilation Balloon Catheter | Micro-Tech (Nanjing) Co., Ltd. | 2015-10-16 | Traditional | PDF ↗ |
| K152524 | Entuit Secure Gastrointestinal Suture Anchor Set, Entuit Secure Adjustable Gastrointestinal Suture Anchor Set | Cook Incorporated | 2015-09-30 | Special | PDF ↗ |
| K152069 | Exodus Array Multipurpose Drainage Catheter, Exodus Nuance Nephrostomy Drainage Catheter, Exodus Believe Biliary Drainage Catheter | Navilyst Medical, Inc. | 2015-09-24 | Traditional | PDF ↗ |
| K143609 | Gyrus ACMI - EZDilate 3-Stage Balloon Dilatation Catheter | Olympus Surgical Technologies America | 2015-03-27 | Traditional | PDF ↗ |
| K143303 | Single Use Biliary Balloon Dilator | Olympus Medical Systems Corp. | 2015-02-27 | Traditional | PDF ↗ |
| K141408 | RESOLVE BILIARY LOCKING DRAINAGE CATHETER | Merit Medical Systems, Inc. | 2014-11-26 | Traditional | PDF ↗ |
| K141335 | EXPEL APD DRAINAGE CATHETER SYSTEM | Boston Scientific Corp | 2014-10-17 | Traditional | PDF ↗ |
| K141597 | MUSTANG BALLOON DIALATION CATHETER | Boston Scientific Corporation | 2014-08-22 | Special | PDF ↗ |
| K133110 | EXPRESS LD BILIARY PREMOUNTED STENT SYSTEM | Boston Scientific Corporation | 2014-07-02 | Traditional | PDF ↗ |
| K140760 | BONASTENT BILIARY | Endochoice, Inc. | 2014-06-16 | Traditional | PDF ↗ |
| K140630 | WALLFLEX BILIARY RX STENT SYSTEM | Boston Scientific | 2014-05-23 | Traditional | PDF ↗ |
| K133700 | ADVANIX PANCREATIC STENT AND NAVIFLEX RAPID EXCHANGE PANCREATIC DELIVERY SYSTEM AND PUSHERS | Boston Scientific Corporation | 2014-05-14 | Traditional | PDF ↗ |
| K130981 | FLEXSTENT BILIARY SELF EXPANDING STENT SYSTEM; S.M.A.R.T. RE-FLEX BILIARY ELF-EXPANDING STENT SYSTEM | Cordis Corp. | 2014-03-12 | Traditional | PDF ↗ |
| K131201 | ENTUIT SECURE GASTROINTESTIONAL SUTURE ANCHOR SET, ENTUIT SECURE ADJUSTABLE GASTROINTESTINAL SUTURE ANCHOR SET | Cook, Inc. | 2013-10-07 | Traditional | PDF ↗ |
| K130792 | LIFESTENT BILIARY STENT SYSTEM, LIFESTENT XL BILIARY STENT SYSTEM | C.R. Bard, Inc. | 2013-08-30 | Traditional | PDF ↗ |
| K130484 | MAXFORCE BILIARY DILATATION CATHETER AND HURRICANE RX BILIARY CATHETER | Boston Scientific Corp | 2013-08-09 | Special | PDF ↗ |
| K130591 | SUPERA VERITAS | Idev Technologies, Inc. | 2013-05-02 | Traditional | PDF ↗ |
| K121430 | EVOLUTION BILIARY STENT SYSTEM | Cook Ireland, Ltd. | 2013-03-01 | Traditional | PDF ↗ |
| K122546 | SUPERA VERITAS INTERWOVEN SELF-EXPANDING NITINOL STENT TRANSHEPATIC BILIARY SYSTEM | Idev Technologies, Inc. | 2012-12-07 | Traditional | PDF ↗ |
| K122072 | WALLFLEXTM BILIARY RX STENT SYSTEM (UNCOVERED, PARTIALLY COVERED, AND FULLY COVERED) WALLFLEXTM BILIARY TRANSHEPATIC STE | Boston Scientific Corporation | 2012-09-28 | Traditional | PDF ↗ |
| K111627 | SUPERA VERITAS(R) INTERWOVEN SELF-EXPANDING NITINOL STENT TRANSHEPATIC BILIARY SYSTEM | Idev Technologies, Inc. | 2012-08-21 | Traditional | PDF ↗ |
| K121832 | RESOLVE BILIARY LOCKING DRAINAGE CATHETER | Merit Medical Systems, Inc. | 2012-07-17 | Special | PDF ↗ |
| K121125 | FLEXSTENT BILIARY SELF-EXPANDING STENT SYSTEM | Flexible Stenting Solutions, Inc. | 2012-07-06 | Traditional | PDF ↗ |
| K113582 | ARCHSTENT BILIARY SYSTEM | Ostial Corporation | 2012-06-29 | Traditional | PDF ↗ |
| K120452 | FLEXSTENT BILIARY SELF-EXPANDING STENT SYSTEM | Flexible Stenting Solutions, Inc. | 2012-04-24 | Traditional | PDF ↗ |
| K112994 | CRE DITATATION BALLON | Boston Scientific Corporation | 2012-02-10 | Traditional | PDF ↗ |
| K111149 | HANAROSTENT BILIARY (NNN) | M.I.Tech Co., Ltd. | 2011-12-30 | Traditional | PDF ↗ |
| K112522 | FLEXSTENT BILIARY SELF-EXPANDING STENT SYSTEM | Flexible Stenting Solutions, Inc. | 2011-12-30 | Traditional | PDF ↗ |
| K112543 | WALLFLEX BILIARY TRANSHEPATIC UNCOVERED STENT SYSTEM, WALLFLEX BILIARY TRANSHEPATIC COVERED STENT SYSTEM | Boston Scientific Corporation | 2011-12-29 | Traditional | PDF ↗ |
| K112701 | CHARGER BALLOON DILATATION CATHETER | Boston Scientific | 2011-10-25 | Special | PDF ↗ |
| K111766 | SUPERA VERITAS INTERWOVEN SELF-EXPANDING NITINOL STENT TRANSHEPTIC BILIARY SYSTEMS | Idev Technologies, Inc. | 2011-10-19 | Traditional | PDF ↗ |
| K111315 | MULTIPURPOSE DRAINAGE CATHETER | Navilyst Medical, Inc. | 2011-06-08 | Special | PDF ↗ |
| K110122 | MUSTANG BALLOON DILATAION CATHETERS | Boston Scientific | 2011-05-12 | Traditional | PDF ↗ |
| K103478 | SINGLE USE BILIARY DRAINAGE STENT V | Olympus Medical Systems Corporation | 2011-02-24 | Traditional | PDF ↗ |
| K103353 | MULTIPURPOSE DRAINAGE CATHETER; NEPHROSTOMY DRAINAGE CATHETER; BILIARY DRAINAGE CATHETER | Navilyst Medical, Inc. | 2011-01-14 | Special | PDF ↗ |
| K102519 | FLEXSTENT BILIARY SELF EXPANDING STENT SYSTEM MODEL FLX-DDLLL-BX | Flexible Stenting Solutions, Inc. | 2010-11-22 | Traditional | PDF ↗ |
| K093893 | SUPERA VERITAS INTERWOVEN SELF-EXPANDING NITINOL STENT TRANSHEPATIC BILIARY SYSTEM | Idev Technologies, Inc. | 2010-10-05 | Traditional | PDF ↗ |
Product code FGE · Class II · Gastroenterology, Urology. Data: openFDA.