Stents, Drains And Dilators For The Biliary Ducts
FDA product code FGE · 462 cleared devices
Class 2
Gastroenterology, Urology
- Regulation
- 21 CFR 876.5010
- Review panel
- GU
- Implant
- Yes
- Life sustaining
- Yes
- Third party review
- No
- GMP exempt
- No
- Clearance span
- 1982-08-10 – 2026-09-18
FGE
2026-09-18
FGE
2026-09-17
Protégé™ EverFlex™ Self-expanding Peripheral Stent System
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FGE
2026-07-27
ARCHIMEDES Biodegradable Stent (Medium)
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FGE
2026-06-24
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
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FGE
2026-04-24
Dilation Balloon Catheter
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FGE
2026-04-16
Endoflux™ Biliary & Pancreatic Stent Sets
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FGE
2026-03-13
BARE Wireguided Balloon Dilation Catheter (1235)
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FGE
2026-03-06
Single use stone retrieval balloons
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FGE
2025-12-29
Niti-S Biliary Stent; Niti-S Biliary Slim M Stent
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FGE
2025-12-22
BIOTEQ Drainage Catheter Set: BT-PD1-SERIES-G and BT-PDS-SERIES-G
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FGE
2025-10-21
Disposable Balloon Catheter (B5-2Q); Disposable Balloon Catheter (B7-2Q); Disposable Balloon Catheter (B7-2LA)
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FGE
2025-08-20
EndoFix™Tissue Fixation System
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FGE
2025-07-16
ARCHIMEDES Biodegradable Pancreatic Stent
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FGE
2025-07-03
Advanix™ Pancreatic Stent and NaviFlex™ Rapid Exchange (RX) Pancreatic Delivery System and Pushers
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FGE
2025-06-25
EGIS Biliary Double Bare Stent (BDB080405)
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FGE
2024-12-20
Single-use Balloon Dilatation Catheter
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FGE
2024-12-17
Tornus ES
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FGE
2024-12-06
WallFlex Biliary PLUS RX Stent System
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FGE
2024-08-30
WallFlex Biliary RX Stent System; Epic Biliary Stent System; WallFlex Biliary RX Fully Covered Stent System RMV
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FGE
2024-06-14
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)
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FGE
2024-02-15
VedDilator ^TM (3-Stage Balloon Dilation Catheter)
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FGE
2023-09-27
EndoGI S-Path Biliary Stent System
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FGE
2023-09-21
EGIS Biliary Single Bare Stent
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FGE
2023-09-06
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
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FGE
2023-06-15
WallFlex™ Biliary RX Stent System
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FGE
2023-05-26
Niti-S Biliary Speed D Stent
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FGE
2023-03-09
MultiStage Balloon Dilatation Catheter
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FGE
2022-12-29
Advanix™ Pancreatic Stent and NaviFlex™ Rapid Exchange (RX) Pancreatic Delivery System and Pushers
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FGE
2022-09-28
EndoGI S-Path Biliary Stent System
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FGE
2022-06-09
Niti-S Biliary Slim M Stent
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FGE
2022-05-09
Compass BDS Biliary Stent
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FGE
2022-05-06
Sterile Biliary Stone Retrieval Balloon Catheter, Retrieval Balloon / short-wire compatible
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FGE
2022-04-13
BIOTEQ Drainage Catheter BT-PDS-series
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FGE
2021-05-11
HANAROSTENT Benefit Biliary (NNN)
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FGE
2020-12-18
Advanix Biliary Stent with NaviFlex RX Delivery System
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FGE
2020-10-09
BIOTEQ Drainage Catheter Set (One Step Type)
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FGE
2020-09-24
EndoGI S-Path Biliary Stent System
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FGE
2020-06-26
EndoGI Biliary Stent System
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FGE
2019-03-14
ConvertX Biliary Stent System
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FGE
2019-02-11
HANAROSTENT FASTTM Biliary (NNN)
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FGE
2018-11-16
Zilver 518 Biliary Stent, Zilver 635 Biliary Stent
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FGE
2018-10-15
Reliant(TM) Multistage Dilatation Balloon Catheter
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FGE
2018-07-06
Nasal Biliary Drainage Set, Liguory Nasal Biliary Drainage Set, Nagaraja Nasal Biliary Drainage Set, Leung Nasal Biliary Drainage Set
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FGE
2018-05-01
Gordon Large-Bore Curved Drainage Catheter, Nephrostomy Pigtail Drainage Catheter, Percutaneous Nephrostomy Set, Pigtail Drainage Catheter Needle Set, Multipurpose Drainage Catheters and Sets
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FGE
2018-03-09
Zimmon Pancreatic Stents/Stent sets, Geenen Pancreatic Stents/Stent Sets, Pushing Catheter and Guiding Catheter, Johlin Pancreatic Wedge Stent and Introducer Set
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FGE
2018-03-08
Gyrus ACMI – EZDilate 3-Stage Balloon Dilatation Catheter
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FGE
2018-02-27
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
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FGE
2017-10-13
Cotton Graduated Dilation Catheter, Fusion Biliary Dilation Catheter, Soehendra Biliary Dilation Catheter, Geenen Graduated Dilation Catheter
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FGE
2017-10-04
CRE RX Biliary Balloon Dilatation Catheter
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FGE
2017-08-09
Epic Biliary Endoscopic Stent System
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FGE
2017-07-31
Nasal Pancreatic Drainage Set
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FGE
2017-06-16
Quantum TTC Biliary Balloon Dilator
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FGE
2017-05-08
GORE VIABIL Short Wire Biliary Endoprosthesis
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FGE
2017-03-30
AngioDynamics Total Abscession Biliary Drainage Catheter
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FGE
2017-02-07
Zilver 518TM Biliary Stent; Zilver 635TM Biliary Stent
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FGE
2017-01-25
Reliant Multistage Dilatation Balloon Catheter
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FGE
2016-12-23
Zilver 635 Biliary Stent
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FGE
2016-10-12
Express SD Biliary Monorail Premounted Stent System
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FGE
2016-05-04
Soehendra Stent Retriever
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FGE
2016-02-12
X-Suit NIR Biliary Metallic Stent
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FGE
2013-10-07
ENTUIT SECURE GASTROINTESTIONAL SUTURE ANCHOR SET, ENTUIT SECURE ADJUSTABLE GASTROINTESTINAL SUTURE ANCHOR SET
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FGE
2013-08-30
LIFESTENT BILIARY STENT SYSTEM, LIFESTENT XL BILIARY STENT SYSTEM
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FGE
2013-08-09
MAXFORCE BILIARY DILATATION CATHETER AND HURRICANE RX BILIARY CATHETER
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FGE
2013-05-02
SUPERA VERITAS
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FGE
2013-03-01
EVOLUTION BILIARY STENT SYSTEM
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FGE
2012-12-07
SUPERA VERITAS INTERWOVEN SELF-EXPANDING NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
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FGE
2012-09-28
WALLFLEXTM BILIARY RX STENT SYSTEM (UNCOVERED, PARTIALLY COVERED, AND FULLY COVERED) WALLFLEXTM BILIARY TRANSHEPATIC STE
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FGE
2012-08-21
SUPERA VERITAS(R) INTERWOVEN SELF-EXPANDING NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
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FGE
2012-07-17
RESOLVE BILIARY LOCKING DRAINAGE CATHETER
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FGE
2012-07-06
FLEXSTENT BILIARY SELF-EXPANDING STENT SYSTEM
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FGE
2012-06-29
ARCHSTENT BILIARY SYSTEM
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FGE
2012-04-24
FLEXSTENT BILIARY SELF-EXPANDING STENT SYSTEM
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FGE
2012-02-10
CRE DITATATION BALLON
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FGE
2011-12-30
FLEXSTENT BILIARY SELF-EXPANDING STENT SYSTEM
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FGE
2011-12-30
HANAROSTENT BILIARY (NNN)
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FGE
2011-12-29
WALLFLEX BILIARY TRANSHEPATIC UNCOVERED STENT SYSTEM, WALLFLEX BILIARY TRANSHEPATIC COVERED STENT SYSTEM
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FGE
2011-10-25
CHARGER BALLOON DILATATION CATHETER
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FGE
2011-10-19
SUPERA VERITAS INTERWOVEN SELF-EXPANDING NITINOL STENT TRANSHEPTIC BILIARY SYSTEMS
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FGE
2011-06-08
MULTIPURPOSE DRAINAGE CATHETER
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FGE
2011-05-12
MUSTANG BALLOON DILATAION CATHETERS
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FGE
2011-02-24
SINGLE USE BILIARY DRAINAGE STENT V
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FGE
2011-01-14
MULTIPURPOSE DRAINAGE CATHETER; NEPHROSTOMY DRAINAGE CATHETER; BILIARY DRAINAGE CATHETER
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FGE
2010-11-22
FLEXSTENT BILIARY SELF EXPANDING STENT SYSTEM MODEL FLX-DDLLL-BX
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FGE
2010-10-05
SUPERA VERITAS INTERWOVEN SELF-EXPANDING NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
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FGE
2010-08-23
EXTRACTOR PRO RX RETRIEVAL BALLONS, EXTRACTOR PRO XL RETRIEVAL BALLONS, EXTRACTOR PRO DL RETRIEVAL BALLONS MODEL M005470
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FGE
2010-07-23
ADVANIX DOUBLE PIGTAIL BILIARY STENT
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FGE
2010-07-23
ADVANIX BILIARY STENT WITH NAVIFLEX RX DELIVERY SYSTEM
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FGE
2010-07-19
DIRECT PERORAL CHOLANGIOSCOPY BALLOON
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FGE
2010-03-24
BONASTENT BILIARY
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FGE
2010-03-16
SCUBA BILIARY STENT SYSTEM
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FGE
2010-01-21
ALIMAXX-B UNCOVERED BILIARY STENT SYSTEM ENDOSCOPIC
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FGE
2009-12-31
MULTIPURPOSE, NEPHROSTOMY AND BILIARY DRAINAGE CATHETERS
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FGE
2009-09-15
FLEXSTENT BILIARY SELF EXPANDING STENT SYSTEM
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FGE
2009-07-29
BULLSEYE BILIARY STENT SYSTEM
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FGE
2009-04-22
WALLFLEX BILIARY RX PARTIALLY-COVERED STENT SYSTEM
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FGE
2009-04-07
WALLFLEX BILIARY RX FULLY-COVERED STENT SYSTEM, MODEL M00570500,M00570510, M00570520, M00570530, M00570540
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FGE
2009-02-20
CONNEX GASTROINTESTINAL SUTURE ANCHOR, MODEL GIAS
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FGE
2009-01-09
MEDINOL X-SUIT NIR BILIARY METALLIC STENT
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FGE
2008-11-19
NITI-S BILIARY STENT
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FGE
2008-10-27
10MM X 40MM UNCOVERED WALLFLEX BILLIARY RX STENT SYSTEM, MODEL M00570890
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