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)
Top companies in FGE
| Company | 510(k)s | Recalls |
|---|---|---|
| Boston Scientific | 56 | 81 |
| Ev3 Corporation | 12 | 71 |
| Bard Peripheral Vascular, Inc. | 2 | 69 |
| Edwards Lifesciences, LLC | 7 | 52 |
| Cordis Corp. | 38 | 14 |
| Cook Medical Incorporated | 0 | 39 |
| Cook Incorporated | 22 | 13 |
| Wilson-Cook Medical, Inc. | 20 | 15 |
| Hobbs Medical, Inc. | 3 | 21 |
| Guidant Corp. | 20 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 7, 2022 | Hobbs Medical, Inc. Freeman Pancreatic Flexi-Stent
Catalog Number: 6534 Open, Classified |
FGE | K834351 |
| Oct 7, 2022 | Hobbs Medical, Inc. Freeman Pancreatic Flexi-Stent
Catalog Number: 6533 Open, Classified |
FGE | K834351 |
| Oct 7, 2022 | Hobbs Medical, Inc. Freeman Pancreatic Flexi-Stent Kit (containing 6568)
Catalog Number: 6529 Open, Classified |
FGE | K834351 |
| Oct 7, 2022 | Hobbs Medical, Inc. Freeman Pancreatic Flexi-Stent Kit (containing 6567)
Catalog Number: 6519 Open, Classified |
FGE | K834351 |
| Oct 7, 2022 | Hobbs Medical, Inc. Freeman Pancreatic Flexi-Stent Kit (containing 6566)
Catalog Number: 6518 Open, Classified |
FGE | K834351 |
| Oct 7, 2022 | Hobbs Medical, Inc. Freeman Pancreatic Flexi-Stent Kit (containing 6533)
Catalog Number: 6507 Open, Classified |
FGE | K834351 |
| Oct 7, 2022 | Hobbs Medical, Inc. Freeman Pancreatic Flexi-Stent Kits: Single Pigtail (containing 6544)
Catalog Number: 6503 Open, Classified |
FGE | K834351 |
| Oct 7, 2022 | Hobbs Medical, Inc. Freeman Pancreatic Flexi-Stent Kits: Single Pigtail
Catalog Number: 6501 Open, Classified |
FGE | K834351 |
| Oct 7, 2022 | Hobbs Medical, Inc. Freeman Pancreatic Flexi-Stent Kit
Catalog Number: 6352 Open, Classified |
FGE | K834351 |
| Oct 7, 2022 | Hobbs Medical, Inc. Freeman Pancreatic Flexi-Stent Kit
Catalog Number: 6351 Open, Classified |
FGE | K834351 |
| Oct 7, 2022 | Hobbs Medical, Inc. Freeman Pancreatic Flexi-Stent Kit (containing 6352)
Catalog Number: 6321 Open, Classified |
FGE | K834351 |
| May 20, 2022 | Cordis US Corp PALMAZ GENESIS Transhepatic Biliary Stent on OPTA PRO .035" Delivery System, Catalog numbers PG2990BPS, PG2990BPX, PG3990BPS, PG3990BPX. Open, Classified |
FGE | K033394 |
| Oct 21, 2021 | Boston 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 |
FGE | K130484 |
| Oct 21, 2021 | Boston 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 |
FGE | K130484 |
| Oct 21, 2021 | Boston 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 |
FGE | K130484 |
| Oct 21, 2021 | Boston 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 |
FGE | K130484 |
| Oct 21, 2021 | Boston 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 |
FGE | K130484 |
| Oct 21, 2021 | Boston 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 |
FGE | K130484 |
| Oct 21, 2021 | Boston 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 |
FGE | K130484 |
| Oct 21, 2021 | Boston 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 |
FGE | K130484 |
| Oct 1, 2021 | Cordis 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 |
FGE | K121125 |
| Oct 1, 2021 | Cordis 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 |
FGE | K121125 |
| Oct 1, 2021 | Cordis 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 |
FGE | K121125 |
| Oct 1, 2021 | Cordis 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 |
FGE | K121125 |
| Oct 1, 2021 | Cordis 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 |
FGE | K121125 |
| Oct 1, 2021 | Cordis 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 |
FGE | K121125 |
| Apr 5, 2021 | W.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 |
FGE | K081184 |
| Jan 4, 2021 | Aomori Olympus Co., Ltd. PBD-203-0710 BILIARY STENT, model no. PBD-203-0710 -Product Usage: Used with endoscopes for endoscopic retrograde biliary drainage. Terminated |
FGE | K933200 |
| Jan 4, 2021 | Aomori Olympus Co., Ltd. PBD-203-0707 BILIARY STENT, model no. PBD-203-0707 -Product Usage: Used with endoscopes for endoscopic retrograde biliary drainage. Terminated |
FGE | K933200 |
| Jan 4, 2021 | Aomori Olympus Co., Ltd. PBD-203-0704 BILIARY STENT, model no. PBD-203-0704 -Product Usage: Used with endoscopes for endoscopic retrograde biliary drainage. Terminated |
FGE | K933200 |
| Jan 4, 2021 | Aomori Olympus Co., Ltd. PBD-203-0703 BILIARY STENT, model no. PBD-203-0703 - Product Usage: Used with endoscopes for endoscopic retrograde biliary drainage. Terminated |
FGE | K933200 |
| Jan 4, 2021 | Aomori 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 |
FGE | K950729 |
| Jan 4, 2021 | Aomori 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 |
FGE | K091495 |
| Jan 4, 2021 | Aomori 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 |
FGE | K091495 |
| Jan 4, 2021 | Aomori 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 |
FGE | K091495 |
| Jan 4, 2021 | Aomori 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 |
FGE | K962925 |
| Jan 4, 2021 | Aomori 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 |
FGE | K962925 |
| Jan 4, 2021 | Aomori 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 |
FGE | K962925 |
| Jan 4, 2021 | Aomori 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 |
FGE | K962925 |
| Jan 4, 2021 | Aomori 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 |
FGE | K962925 |
| Sep 16, 2020 | Boston 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 |
FGE | K130484 |
| Aug 7, 2020 | Boston 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 |
FGE | K140630 |
| Nov 25, 2019 | Boston Scientific Corporation Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 18cm
UPN: M00536730 Terminated |
FGE | K133700 |
| Nov 25, 2019 | Boston Scientific Corporation Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 15cm
UPN: M005337206 Terminated |
FGE | K133700 |
| Nov 25, 2019 | Boston Scientific Corporation Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 13cm
UPN: M00536710 Terminated |
FGE | K133700 |
| Nov 25, 2019 | Boston Scientific Corporation Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 12cm
UPN: M00536700 Terminated |
FGE | K133700 |
| Nov 25, 2019 | Boston Scientific Corporation Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 11cm
UPN: M005336690 Terminated |
FGE | K133700 |
| Nov 25, 2019 | Boston Scientific Corporation Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 10cm
UPN: M005336680 Terminated |
FGE | K133700 |
| Nov 25, 2019 | Boston Scientific Corporation Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 9cm
UPN: M00536670 Terminated |
FGE | K133700 |
| Nov 25, 2019 | Boston Scientific Corporation Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 8cm
UPN: M00536660 Terminated |
FGE | K133700 |
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