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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

DateFirm and productCodeLinked 510(k)
Oct 7, 2022Hobbs Medical, Inc.
Freeman Pancreatic Flexi-Stent Catalog Number: 6534
Open, Classified
FGEK834351
Oct 7, 2022Hobbs Medical, Inc.
Freeman Pancreatic Flexi-Stent Catalog Number: 6533
Open, Classified
FGEK834351
Oct 7, 2022Hobbs Medical, Inc.
Freeman Pancreatic Flexi-Stent Kit (containing 6568) Catalog Number: 6529
Open, Classified
FGEK834351
Oct 7, 2022Hobbs Medical, Inc.
Freeman Pancreatic Flexi-Stent Kit (containing 6567) Catalog Number: 6519
Open, Classified
FGEK834351
Oct 7, 2022Hobbs Medical, Inc.
Freeman Pancreatic Flexi-Stent Kit (containing 6566) Catalog Number: 6518
Open, Classified
FGEK834351
Oct 7, 2022Hobbs Medical, Inc.
Freeman Pancreatic Flexi-Stent Kit (containing 6533) Catalog Number: 6507
Open, Classified
FGEK834351
Oct 7, 2022Hobbs Medical, Inc.
Freeman Pancreatic Flexi-Stent Kits: Single Pigtail (containing 6544) Catalog Number: 6503
Open, Classified
FGEK834351
Oct 7, 2022Hobbs Medical, Inc.
Freeman Pancreatic Flexi-Stent Kits: Single Pigtail Catalog Number: 6501
Open, Classified
FGEK834351
Oct 7, 2022Hobbs Medical, Inc.
Freeman Pancreatic Flexi-Stent Kit Catalog Number: 6352
Open, Classified
FGEK834351
Oct 7, 2022Hobbs Medical, Inc.
Freeman Pancreatic Flexi-Stent Kit Catalog Number: 6351
Open, Classified
FGEK834351
Oct 7, 2022Hobbs Medical, Inc.
Freeman Pancreatic Flexi-Stent Kit (containing 6352) Catalog Number: 6321
Open, Classified
FGEK834351
May 20, 2022Cordis US Corp
PALMAZ GENESIS Transhepatic Biliary Stent on OPTA PRO .035" Delivery System, Catalog numbers PG2990BPS, PG2990BPX, PG3990BPS, PG3990BPX.
Open, Classified
FGEK033394
Oct 21, 2021Boston Scientific Corporation
HURRICANE RX DILATION BALLOON 10MM 4CM -for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. UPN: M00545960
Open, Classified
FGEK130484
Oct 21, 2021Boston Scientific Corporation
HURRICANE RX DILATION BALLOON 10MM 2CM -for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. UPN: M00545950
Open, Classified
FGEK130484
Oct 21, 2021Boston Scientific Corporation
HURRICANE RX DILATION BALLOON 8MM 4CM -for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. UPN: M00545940
Open, Classified
FGEK130484
Oct 21, 2021Boston Scientific Corporation
HURRICANE RX DILATION BALLOON 8MM 2CM -for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. UPN: M00545930
Open, Classified
FGEK130484
Oct 21, 2021Boston Scientific Corporation
HURRICANE RX DILATION BALLOON 6MM 4CM- -for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. UPN: M00545920
Open, Classified
FGEK130484
Oct 21, 2021Boston Scientific Corporation
HURRICANE RX DILATION BALLOON 6MM 2CM-for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. UPN:M00545910
Open, Classified
FGEK130484
Oct 21, 2021Boston Scientific Corporation
HURRICANE RX DILATION BALLOON 4MM 4CM-for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. UPN: M00545900
Open, Classified
FGEK130484
Oct 21, 2021Boston Scientific Corporation
HURRICANE RX DILATION BALLOON 4MM 2CM-for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. UPN: M00545890
Open, Classified
FGEK130484
Oct 1, 2021Cordis Corporation
SMART FLEX 10x100 BIL, 120cm The S.M.A.R.T. Flex Biliary Stent System is indicated for use in the palliation of malignant strictures in the biliary tree.
Open, Classified
FGEK121125
Oct 1, 2021Cordis Corporation
SMART FLEX 10x100 BIL, 80cm The S.M.A.R.T. Flex Biliary Stent System is indicated for use in the palliation of malignant strictures in the biliary tree.
Open, Classified
FGEK121125
Oct 1, 2021Cordis Corporation
SMART FLEX 8x60 BIL, 80cm The S.M.A.R.T. Flex Biliary Stent System is indicated for use in the palliation of malignant strictures in the biliary tree.
Open, Classified
FGEK121125
Oct 1, 2021Cordis Corporation
SMART FLEX 6x150 BIL, 120cm The S.M.A.R.T. Flex Biliary Stent System is indicated for use in the palliation of malignant strictures in the biliary tree.
Open, Classified
FGEK121125
Oct 1, 2021Cordis Corporation
SMART FLEX 6x120 BIL, 120cm The S.M.A.R.T. Flex Biliary Stent System is indicated for use in the palliation of malignant strictures in the biliary tree.
Open, Classified
FGEK121125
Oct 1, 2021Cordis Corporation
SMART FLEX 9x60 BIL, 80cm The S.M.A.R.T. Flex Biliary Stent System is indicated for use in the palliation of malignant strictures in the biliary tree.
Open, Classified
FGEK121125
Apr 5, 2021W.L. Gore & Associates, Inc.
GORE VIBIL Biliary Endoprosthesis: stents, drains and dilators for the biliary ducts. Catalogue numbers: VH1008040, VH1010040, VN1010040, VN0808200 - Product Usage: intended for palliation of malignan
Terminated
FGEK081184
Jan 4, 2021Aomori Olympus Co., Ltd.
PBD-203-0710 BILIARY STENT, model no. PBD-203-0710 -Product Usage: Used with endoscopes for endoscopic retrograde biliary drainage.
Terminated
FGEK933200
Jan 4, 2021Aomori Olympus Co., Ltd.
PBD-203-0707 BILIARY STENT, model no. PBD-203-0707 -Product Usage: Used with endoscopes for endoscopic retrograde biliary drainage.
Terminated
FGEK933200
Jan 4, 2021Aomori Olympus Co., Ltd.
PBD-203-0704 BILIARY STENT, model no. PBD-203-0704 -Product Usage: Used with endoscopes for endoscopic retrograde biliary drainage.
Terminated
FGEK933200
Jan 4, 2021Aomori Olympus Co., Ltd.
PBD-203-0703 BILIARY STENT, model no. PBD-203-0703 - Product Usage: Used with endoscopes for endoscopic retrograde biliary drainage.
Terminated
FGEK933200
Jan 4, 2021Aomori Olympus Co., Ltd.
PR-V614M 2-LUMEN CANNULA, model no. PR-V614M - Product Usage: Used with endoscopes to inject contrast medium in the biliary or pancreatic duct.
Terminated
FGEK950729
Jan 4, 2021Aomori Olympus Co., Ltd.
B-V443Q-A 3-LUMEN EXTRACTION BALLOON V, model no. B-V443Q-A - Product Usage: Used with endoscopes to endoscopically remove stones such as calculi, pancreatic and common bile duct stones.
Terminated
FGEK091495
Jan 4, 2021Aomori Olympus Co., Ltd.
B-V243Q-A 3-LUMEN EXTRACTION BALLOON V, model no. B-V243Q-A - Product Usage: Used with endoscopes to endoscopically remove stones such as calculi, pancreatic and common bile duct stones.
Terminated
FGEK091495
Jan 4, 2021Aomori Olympus Co., Ltd.
B-V233P-A 3-LUMEN EXTRACTION BALLOON V, model no. B-V233P-A - Product Usage: Used with endoscopes to endoscopically remove stones such as calculi, pancreatic and common bile duct stones.
Terminated
FGEK091495
Jan 4, 2021Aomori Olympus Co., Ltd.
B7-2Q BALLOON CATHETER 13MM DIA 3.2, model no. B7-2Q -Product Usage: Used with endoscopes for injection of contrast medium or other medical fluid into the biliary or pancreatic tract.
Terminated
FGEK962925
Jan 4, 2021Aomori Olympus Co., Ltd.
B7-2LA BALLOON CATHETER 13MM DIA 3.2, model no. B7-2LA - Product Usage: Used with endoscopes for injection of contrast medium or other medical fluid into the biliary or pancreatic tract.
Terminated
FGEK962925
Jan 4, 2021Aomori Olympus Co., Ltd.
B7-2C BALLOON CATHETER 13mm dia 2.8; model no. B7-2C - Product Usage: Used with endoscopes to inject contrast medium or other medical fluid into the bile duct, pancreatic duct, and respiratory organs.
Terminated
FGEK962925
Jan 4, 2021Aomori Olympus Co., Ltd.
B5-2C BALLOON CATHETER 11MM DIA 2.0; Model No. B5-2C - Product Usage: Used with endoscopes to inject contrast medium or other medical fluid into the bile duct, pancreatic duct, and respiratory organs.
Terminated
FGEK962925
Jan 4, 2021Aomori Olympus Co., Ltd.
B5-2Q BALLOON CATHETER, Model No. B5-2Q - Product Usage: Used with endoscopes to inject contrast medium or other medical fluid into the bile duct, pancreatic duct, and respiratory organs.
Terminated
FGEK962925
Sep 16, 2020Boston Scientific Corporation
Hurricane RX Biliary Balloon Dilatation Catheter Catalog REF No. M00545890; M00545900; M00545910; M00545920; M00545930; M00545940; M00545950; M00545960 The device is a double lumen catheter with a ba
Open, Classified
FGEK130484
Aug 7, 2020Boston Scientific Corporation
WallFlexTM Biliary RX Fully Covered Stent System RMV (10mmx60mm Stent) UPN: M00570370 - Product Usage: is indicated for use in the palliative treatment of biliary strictures produced by malignant neop
Terminated
FGEK140630
Nov 25, 2019Boston Scientific Corporation
Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 18cm UPN: M00536730
Terminated
FGEK133700
Nov 25, 2019Boston Scientific Corporation
Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 15cm UPN: M005337206
Terminated
FGEK133700
Nov 25, 2019Boston Scientific Corporation
Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 13cm UPN: M00536710
Terminated
FGEK133700
Nov 25, 2019Boston Scientific Corporation
Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 12cm UPN: M00536700
Terminated
FGEK133700
Nov 25, 2019Boston Scientific Corporation
Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 11cm UPN: M005336690
Terminated
FGEK133700
Nov 25, 2019Boston Scientific Corporation
Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 10cm UPN: M005336680
Terminated
FGEK133700
Nov 25, 2019Boston Scientific Corporation
Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 9cm UPN: M00536670
Terminated
FGEK133700
Nov 25, 2019Boston Scientific Corporation
Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 8cm UPN: M00536660
Terminated
FGEK133700

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