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Panels › Gastroenterology, Urology › Product code FGE · Class 2

Stents, Drains And Dilators For The Biliary Ducts

Regulation 876.5010

10510(k)s in 12 months (478 all time)
12recalls in 12 months (452 all time)
439recalls that name a 510(k)
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Top companies in FGE

Company510(k)sRecalls
Boston Scientific5681
Ev3 Corporation1271
Bard Peripheral Vascular, Inc.269
Edwards Lifesciences, LLC752
Cordis Corp.3814
Cook Medical Incorporated039
Cook Incorporated2213
Wilson-Cook Medical, Inc.2015
Hobbs Medical, Inc.321
Guidant Corp.200
Decided510(k)Device and applicantCode
Sep 18, 2026K254179Drainage Catheter
Canyon Medical, Inc., CN
FGE
Sep 17, 2026K262913Protégé™ EverFlex™ Self-expanding Peripheral Stent System
Medtronic, Inc.
FGE
Jul 27, 2026K260835ARCHIMEDES Biodegradable Stent (Medium)
Q3 Medical USA, LLC (C/O Q3 Medical Devices Ltd.)
FGE
Jun 24, 2026K253393Single-use Balloon Dilatation Catheter (AG-5251-083018 AG-5251-085518 AG-5251-088018 AG-5251-083019 AG-5251-085519 AG-52
Hangzhou AGS MedTech Co., Ltd., CN
FGE
Apr 24, 2026K253832Dilation Balloon Catheter
Mirco-Tech (Nanjing) Co., Ltd., CN
FGE
Apr 16, 2026K251658Endoflux™ Biliary & Pancreatic Stent Sets
Medi-Globe GmbH, DE
FGE
Mar 13, 2026K253987BARE Wireguided Balloon Dilation Catheter (1235)
GIE Medical
FGE
Mar 6, 2026K253132Single use stone retrieval balloons
Zhejiang Chuangxiang Medical Technology Co., Ltd., CN
FGE
Dec 29, 2025K251123Niti-S Biliary Stent; Niti-S Biliary Slim M Stent
Taewoong Medical Co., Ltd., KR
FGE
Dec 22, 2025K251019BIOTEQ Drainage Catheter Set: BT-PD1-SERIES-G and BT-PDS-SERIES-G
Bioteque Corporation, TW
FGE
Oct 21, 2025K250409Disposable Balloon Catheter (B5-2Q); Disposable Balloon Catheter (B7-2Q); Disposable Balloon Catheter (B7-2LA)
Olympus Medical Systems Corporation, JP
FGE
Aug 20, 2025K251229EndoFix™Tissue Fixation System
Softac Medical Technologies
FGE
Jul 16, 2025K243412ARCHIMEDES Biodegradable Pancreatic Stent
Q3 Medical USA, LLC (C/O Q3 Medical Devices Ltd.)
FGE
Jul 3, 2025K251291Advanix™ Pancreatic Stent and NaviFlex™ Rapid Exchange (RX) Pancreatic Delivery System and Pushers
Boston Scientific
FGE
Jun 25, 2025K242845EGIS Biliary Double Bare Stent (BDB080405)
S&G Biotech, Inc., KR
FGE
Dec 20, 2024K241888Single-use Balloon Dilatation Catheter
Leo Medical Co., Ltd., CN
FGE
Dec 17, 2024K241801Tornus ES
Asahi Intecc Co., Ltd., JP
FGE
Dec 6, 2024K242950WallFlex Biliary PLUS RX Stent System
Boston Scientific
FGE
Aug 30, 2024K240464WallFlex Biliary RX Stent System; Epic Biliary Stent System; WallFlex Biliary RX Fully Covered Stent System RMV
Boston Scientific
FGE
Jun 14, 2024K233079Zimmon® Pancreatic Stents/Stent sets (SPSOF, SPSOS, ZEPDF, ZEPDS, ZPSOF, ZPSOS); Geenen® Pancreatic Stents/Stent Sets (G
Cook Ireland, Ltd., IE
FGE
Feb 15, 2024K232245VedDilator ^TM (3-Stage Balloon Dilation Catheter)
Jiangsu Vedkang Medical Science and Technology Co., Ltd., CN
FGE
Sep 27, 2023K232596EndoGI S-Path Biliary Stent System
Endogi Medical, Ltd., IL
FGE
Sep 21, 2023K223354EGIS Biliary Single Bare Stent
S&G Biotech, Inc., KR
FGE
Sep 6, 2023K230127Biliary Plastic Stent, Biliary Plastic Stent Introducer, Biliary Plastic Stent Set, Biliary Plastic Stent Introducer/ sh
Micro-Tech (Nanjing) Co., Ltd., CN
FGE
Jun 15, 2023K223469WallFlex™ Biliary RX Stent System
Boston Scientific Corporation
FGE
May 26, 2023K223626Niti-S Biliary Speed D Stent
Taewoong Medical Co., Ltd., KR
FGE
Mar 9, 2023K222663MultiStage Balloon Dilatation Catheter
Dongguan TT Medical, Inc., CN
FGE
Dec 29, 2022K223592Advanix™ Pancreatic Stent and NaviFlex™ Rapid Exchange (RX) Pancreatic Delivery System and Pushers
Boston Scientific Corporation
FGE
Sep 28, 2022K222627EndoGI S-Path Biliary Stent System
Endo GI Medical, IL
FGE
Jun 9, 2022K221071Niti-S Biliary Slim M Stent
Taewoong Medical Co., Ltd., KR
FGE
May 9, 2022K213946Compass BDS Biliary Stent
Cook Ireland, Ltd., IE
FGE
May 6, 2022K211021Sterile Biliary Stone Retrieval Balloon Catheter, Retrieval Balloon / short-wire compatible
Micro-Tech (Nanjing) Co., Ltd., CN
FGE
Apr 13, 2022K210419BIOTEQ Drainage Catheter BT-PDS-series
Bioteque Corporation, TW
FGE
May 11, 2021K202973HANAROSTENT Benefit Biliary (NNN)
M.I.Tech Co., Ltd., KR
FGE
Dec 18, 2020K203162Advanix Biliary Stent with NaviFlex RX Delivery System
Boston Scientific Corporation
FGE
Oct 9, 2020K200103BIOTEQ Drainage Catheter Set (One Step Type)
Bioteque Corporation, TW
FGE
Sep 24, 2020K202477EndoGI S-Path Biliary Stent System
Endo GI Medical, IL
FGE
Jun 26, 2020K193600EndoGI Biliary Stent System
Endogi Medical, Ltd., IL
FGE
Mar 14, 2019K181669ConvertX Biliary Stent System
Brightwater Medical
FGE
Feb 11, 2019K183396HANAROSTENT FASTTM Biliary (NNN)
M.I.Tech Co., Ltd., KR
FGE
Nov 16, 2018K182980Zilver 518 Biliary Stent, Zilver 635 Biliary Stent
Cook Ireland, Ltd., IE
FGE
Oct 15, 2018K180418Reliant(TM) Multistage Dilatation Balloon Catheter
Micro-Tech (Nanjing) Co., Ltd., CN
FGE
Jul 6, 2018K180868Nasal Biliary Drainage Set, Liguory Nasal Biliary Drainage Set, Nagaraja Nasal Biliary Drainage Set, Leung Nasal Biliary
Cook Ireland, IE
FGE
May 1, 2018K173035Gordon Large-Bore Curved Drainage Catheter, Nephrostomy Pigtail Drainage Catheter, Percutaneous Nephrostomy Set, Pigtail
Cook Incorporated
FGE
Mar 9, 2018K172057Zimmon Pancreatic Stents/Stent sets, Geenen Pancreatic Stents/Stent Sets, Pushing Catheter and Guiding Catheter, Johlin
Cook Ireland, Ltd., IE
FGE
Mar 8, 2018K180086Gyrus ACMI – EZDilate 3-Stage Balloon Dilatation Catheter
Gyrus Acmi, Inc.
FGE
Feb 27, 2018K172044Cotton-Huibregtse Stent, Cotton-Leung Biliary Stent, Cotton-Leung Sof-Flex Biliary Stent, Soehendra Tannenbaum Biliary S
Cook Ireland, Ltd., IE
FGE
Oct 13, 2017K171548Cotton Graduated Dilation Catheter, Fusion Biliary Dilation Catheter, Soehendra Biliary Dilation Catheter, Geenen Gradua
Wilson-Cook Medical, Inc.
FGE
Oct 4, 2017K172520CRE RX Biliary Balloon Dilatation Catheter
Boston Scientific Corporation
FGE
Aug 9, 2017K171809Epic Biliary Endoscopic Stent System
Boston Scientific Corporation
FGE

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