ClearanceBrief
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
Jul 31, 2017K171623Nasal Pancreatic Drainage Set
Cook Ireland, Ltd., IE
FGE
Jun 16, 2017K171223Quantum TTC Biliary Balloon Dilator
Wilson-Cook Medical, Inc.
FGE
May 8, 2017K170740GORE VIABIL Short Wire Biliary Endoprosthesis
W. L. Gore & Associates, Inc.
FGE
Mar 30, 2017K170743AngioDynamics Total Abscession Biliary Drainage Catheter
AngioDynamics, Inc.
FGE
Feb 7, 2017K163169Zilver 518TM Biliary Stent; Zilver 635TM Biliary Stent
Cook Ireland, Ltd., IE
FGE
Jan 25, 2017K162226Reliant Multistage Dilatation Balloon Catheter
Micro-Tech (Nanjing) Co., Ltd., CN
FGE
Dec 23, 2016K163018Zilver 635 Biliary Stent
Cook Ireland, Ltd., IE
FGE
Oct 12, 2016K162404Express SD Biliary Monorail Premounted Stent System
Boston Scientific Corporation
FGE
May 4, 2016K161203Soehendra Stent Retriever
Wilson-Cook Medical, Inc.
FGE
Feb 12, 2016K150487X-Suit NIR Biliary Metallic Stent
Medinol, Ltd., IL
FGE
Nov 20, 2015K152853WALLSTENT RP Endoprosthesis Transhepatic Biliary, WALLSTENT Endoprosthesis Transhepatic Biliary
Boston Scientific Corp
FGE
Nov 6, 2015K151925Elation Wireguided Balloon Dilation Catheter
Merit Medical Systems, Inc.
FGE
Oct 27, 2015K152607Express SD Biliary Monorail Premounted Stent System
Boston Scientific
FGE
Oct 16, 2015K151671Disposable Multistage Dilation Balloon Catheter
Micro-Tech (Nanjing) Co., Ltd., CN
FGE
Sep 30, 2015K152524Entuit Secure Gastrointestinal Suture Anchor Set, Entuit Secure Adjustable Gastrointestinal Suture Anchor Set
Cook Incorporated
FGE
Sep 24, 2015K152069Exodus Array Multipurpose Drainage Catheter, Exodus Nuance Nephrostomy Drainage Catheter, Exodus Believe Biliary Drainag
Navilyst Medical, Inc.
FGE
Mar 27, 2015K143609Gyrus ACMI - EZDilate 3-Stage Balloon Dilatation Catheter
Olympus Surgical Technologies America
FGE
Feb 27, 2015K143303Single Use Biliary Balloon Dilator
Olympus Medical Systems Corp., JP
FGE
Nov 26, 2014K141408RESOLVE BILIARY LOCKING DRAINAGE CATHETER
Merit Medical Systems, Inc.
FGE
Oct 17, 2014K141335EXPEL APD DRAINAGE CATHETER SYSTEM
Boston Scientific Corp
FGE
Aug 22, 2014K141597MUSTANG BALLOON DIALATION CATHETER
Boston Scientific Corporation
FGE
Jul 2, 2014K133110EXPRESS LD BILIARY PREMOUNTED STENT SYSTEM
Boston Scientific Corporation
FGE
Jun 16, 2014K140760BONASTENT BILIARY
Endochoice, Inc., CA
FGE
May 23, 2014K140630WALLFLEX BILIARY RX STENT SYSTEM
Boston Scientific
FGE
May 14, 2014K133700ADVANIX PANCREATIC STENT AND NAVIFLEX RAPID EXCHANGE PANCREATIC DELIVERY SYSTEM AND PUSHERS
Boston Scientific Corporation
FGE
Mar 12, 2014K130981FLEXSTENT BILIARY SELF EXPANDING STENT SYSTEM; S.M.A.R.T. RE-FLEX BILIARY ELF-EXPANDING STENT SYSTEM
Cordis Corp.
FGE
Oct 7, 2013K131201ENTUIT SECURE GASTROINTESTIONAL SUTURE ANCHOR SET, ENTUIT SECURE ADJUSTABLE GASTROINTESTINAL SUTURE ANCHOR SET
Cook, Inc.
FGE
Aug 30, 2013K130792LIFESTENT BILIARY STENT SYSTEM, LIFESTENT XL BILIARY STENT SYSTEM
C.R. Bard, Inc.
FGE
Aug 9, 2013K130484MAXFORCE BILIARY DILATATION CATHETER AND HURRICANE RX BILIARY CATHETER
Boston Scientific Corp
FGE
May 2, 2013K130591SUPERA VERITAS
Idev Technologies, Inc.
FGE
Mar 1, 2013K121430EVOLUTION BILIARY STENT SYSTEM
Cook Ireland, Ltd., IE
FGE
Dec 7, 2012K122546SUPERA VERITAS INTERWOVEN SELF-EXPANDING NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
Idev Technologies, Inc.
FGE
Sep 28, 2012K122072WALLFLEXTM BILIARY RX STENT SYSTEM (UNCOVERED, PARTIALLY COVERED, AND FULLY COVERED) WALLFLEXTM BILIARY TRANSHEPATIC STE
Boston Scientific Corporation
FGE
Aug 21, 2012K111627SUPERA VERITAS(R) INTERWOVEN SELF-EXPANDING NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
Idev Technologies, Inc.
FGE
Jul 17, 2012K121832RESOLVE BILIARY LOCKING DRAINAGE CATHETER
Merit Medical Systems, Inc.
FGE
Jul 6, 2012K121125FLEXSTENT BILIARY SELF-EXPANDING STENT SYSTEM
Flexible Stenting Solutions, Inc.
FGE
Jun 29, 2012K113582ARCHSTENT BILIARY SYSTEM
Ostial Corporation
FGE
Apr 24, 2012K120452FLEXSTENT BILIARY SELF-EXPANDING STENT SYSTEM
Flexible Stenting Solutions, Inc.
FGE
Feb 10, 2012K112994CRE DITATATION BALLON
Boston Scientific Corporation
FGE
Dec 30, 2011K112522FLEXSTENT BILIARY SELF-EXPANDING STENT SYSTEM
Flexible Stenting Solutions, Inc.
FGE
Dec 30, 2011K111149HANAROSTENT BILIARY (NNN)
M.I.Tech Co., Ltd.
FGE
Dec 29, 2011K112543WALLFLEX BILIARY TRANSHEPATIC UNCOVERED STENT SYSTEM, WALLFLEX BILIARY TRANSHEPATIC COVERED STENT SYSTEM
Boston Scientific Corporation
FGE
Oct 25, 2011K112701CHARGER BALLOON DILATATION CATHETER
Boston Scientific
FGE
Oct 19, 2011K111766SUPERA VERITAS INTERWOVEN SELF-EXPANDING NITINOL STENT TRANSHEPTIC BILIARY SYSTEMS
Idev Technologies, Inc.
FGE
Jun 8, 2011K111315MULTIPURPOSE DRAINAGE CATHETER
Navilyst Medical, Inc.
FGE
May 12, 2011K110122MUSTANG BALLOON DILATAION CATHETERS
Boston Scientific
FGE
Feb 24, 2011K103478SINGLE USE BILIARY DRAINAGE STENT V
Olympus Medical Systems Corporation
FGE
Jan 14, 2011K103353MULTIPURPOSE DRAINAGE CATHETER; NEPHROSTOMY DRAINAGE CATHETER; BILIARY DRAINAGE CATHETER
Navilyst Medical, Inc.
FGE
Nov 22, 2010K102519FLEXSTENT BILIARY SELF EXPANDING STENT SYSTEM MODEL FLX-DDLLL-BX
Flexible Stenting Solutions, Inc.
FGE
Oct 5, 2010K093893SUPERA VERITAS INTERWOVEN SELF-EXPANDING NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
Idev Technologies, Inc.
FGE

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