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 14, 2026 | W L Gore & Associates, Inc. Generic Name: GORE VIABIL Short Wire Biliary Endoprosthesis;
Model/Catalog Number: VSWVH0808 and VSWVN1006
Product Description: The GORE VIABIL Short Wire Biliary Endoprosthesis is a flexible, self-ex Open, Classified |
FGE | K170740 |
| Oct 9, 2026 | Boston Scientific Corporation NaviFlex LW Pusher;
Advx Panc. Stent 4/5F;
Material Number (UPN): M00535030; Open, Classified |
FGE | K223592 |
| Sep 18, 2026 | Olympus Corporation of the Americas Olympus EZDilate Endoscopic Balloon Dilator Wired-guided 11, 12, 13mm. Model Number: BD-420X-1355. Open, Classified |
FGE | None listed |
| Aug 7, 2026 | W L Gore & Associates, Inc. GORE VIABIL Short Wire Biliary Endoprosthesis, Model No. VSWVN1006. Flexible, self-expanding endoprosthesis designed to maintain luminal patency of the common bile duct which may be obstructed. Open, Classified |
FGE | K170740 |
| Aug 7, 2026 | W L Gore & Associates, Inc. GORE VIABIL Short Wire Biliary Endoprosthesis, Model No. VSWVN1010. Flexible, self-expanding endoprosthesis designed to maintain luminal patency of the common bile duct which may be obstructed. Open, Classified |
FGE | K170740 |
| Jul 1, 2026 | Boston Scientific Corporation CRE Pro Wireguided 18-20mm 240cm Open, Classified |
FGE | K112994 |
| Jul 1, 2026 | Boston Scientific Corporation CRE Pro Wireguided 15-18mm 240cm Open, Classified |
FGE | K112994 |
| Jul 1, 2026 | Boston Scientific Corporation CRE Pro Wireguided 12-15mm 240cm Open, Classified |
FGE | K112994 |
| Jul 1, 2026 | Boston Scientific Corporation CRE Pro Wireguided 10-12mm 240cm Open, Classified |
FGE | K112994 |
| Jul 1, 2026 | Boston Scientific Corporation CRE Pro Wireguided 8-10mm 240cm Open, Classified |
FGE | K112994 |
| Jul 1, 2026 | Boston Scientific Corporation CRE Pro Wireguided 6-8mm 240cm Open, Classified |
FGE | K112994 |
| Apr 6, 2026 | Cook Incorporated COOK MEDICAL Multipurpose Drainage Catheter: Reference Part Number ULT8.5-38-25-P-CLMS-8-RH-FS, Order Number G29775 Open, Classified |
FGE | K173035 |
| Sep 23, 2025 | Boston Scientific Corporation Extractor Pro RX Retrieval Balloon Catheter;
UPN (REF): (1) M00547030 (9-12mm Below), (2) M00547000 (9-12mm Above); Open, Classified |
FGE | K102082 |
| Oct 25, 2024 | Olympus Corporation of the Americas EZDilate Wire Guided Balloon- Indicated for use in adult and adolescent (> 12 years) populations to endoscopically dilate strictures of the alimentary tract. It is also indicated in adults for endosco Open, Classified |
FGE | K180086 |
| Jun 27, 2024 | Cook Incorporated Ultrathane Cook-Cope Type Locking Loop Multipurpose Drainage Catheter-ULT12.0-38-45-P-6S-CLM-RH-ntended for percutaneous drainage in a variety of drainage applications (e.g., nephrostomy, biliary and Open, Classified |
FGE | K173035 |
| Jun 27, 2024 | Cook Incorporated Ultrathane Mac-Loc Locking Loop Multipurpose Drainage Catheter ULT16.0-38-25-P-6S-MCL-HC--Intended for percutaneous drainage in a variety of drainage applications (e.g., nephrostomy, biliary and absce Open, Classified |
FGE | K173035 |
| Apr 12, 2024 | Cook Incorporated Dilator - Coons Taper - Used for dilating puncture sites or catheter tracts for percutaneous placement of devices for vascular and non-vascular applications such as in the venous, arterial, biliary an Open, Classified |
FGE | K183036 |
| Apr 12, 2024 | Cook Incorporated Dilator With AQ Hydrophilic Coating - Intended to be used for dilating puncture sites or catheter tracts for percutaneous placement of devices for vascular and non-vascular applications such as in the Open, Classified |
FGE | K183036 |
| Apr 12, 2024 | Cook Incorporated Dilator - Intended to be used for dilating puncture sites or catheter tracts for percutaneous placement of devices for vascular and non-vascular applications such as in the venous, arterial, biliary a Open, Classified |
FGE | K183036 |
| Apr 12, 2024 | Cook Incorporated Entuit Secure Adjustable Gastrointestinal Suture Anchor Set - Intended for anchoring the anterior wall of the stomach to the abdominal wall prior to introduction of interventional catheters.
REFERE Open, Classified |
FGE | K152524 |
| Feb 22, 2024 | W.L. Gore & Associates, Inc. GORE VIABIL Short Wire Biliary Endoprosthesis, Product labeled as
(1) Catalog Number VSWVH1008, 10 mm x 8 cm;
with holes; and
(2) Catalog Number VSWVN1008, 10 mm x 8 cm;
no holes Open, Classified |
FGE | K170740 |
| Jan 31, 2024 | Olympus Corporation of the Americas EZDilate Wire Guided Balloon 18-19-20. Indicated for endoscopic
dilation of strictures in the alimentary tract in adults and adolescents (>12 years).
Model: BD-410X-2055 Open, Classified |
FGE | K180086 |
| Jan 31, 2024 | Olympus Corporation of the Americas EZDilate Wire Guided Balloon 16-17-18. Indicated for endoscopic
dilation of strictures in the alimentary tract in adults and adolescents (>12 years).
Model: BD-410X-1855 Open, Classified |
FGE | K180086 |
| Jan 31, 2024 | Olympus Corporation of the Americas EZDilate Wire Guided Balloon 13.5-14.5-15.5. Indicated for endoscopic
dilation of strictures in the alimentary tract in adults and adolescents (>12 years).
Model: BD-410X-1555 Open, Classified |
FGE | K180086 |
| Jan 31, 2024 | Olympus Corporation of the Americas EZDilate Wire Guided Balloon 11-12-13. Indicated for endoscopic
dilation of strictures in the alimentary tract in adults and adolescents (>12 years).
Model: BD-410X-1355 Open, Classified |
FGE | K180086 |
| Jan 31, 2024 | Olympus Corporation of the Americas EZDilate Wire Guided Balloon 8.5-9.5-10.5. indicated for endoscopic
dilation of strictures in the alimentary tract in adults and adolescents (>12 years)
Model: BD-410X-1055 Open, Classified |
FGE | K180086 |
| Jan 31, 2024 | Olympus Corporation of the Americas EZDilate Wire Guided Balloon 6-7-8. indicated for endoscopic
dilation of strictures in the alimentary tract in adults and adolescents (>12 years)
Model: BD-410X-0855 Open, Classified |
FGE | K180086 |
| Jan 31, 2024 | Olympus Corporation of the Americas EZDilate Fixed Wire Balloon 18-19-20. Indicated for endoscopic dilation of strictures of the esophagus in adults and adolescents (>12 years).
Model: BD-400P-2080 Open, Classified |
FGE | K180086 |
| Jan 31, 2024 | Olympus Corporation of the Americas EZDilate Fixed Wire Balloon 16-17-18. Indicated for endoscopic dilation of strictures of the esophagus in adults and adolescents (>12 years).
Model: BD-400P-1880 Open, Classified |
FGE | K180086 |
| Jan 31, 2024 | Olympus Corporation of the Americas EZDilate Fixed Wire Balloon 13.5-14.5-15.5. Indicated for endoscopic dilation of strictures of the esophagus in adults and adolescents (>12 years).
Model: BD-400P-1580 Open, Classified |
FGE | K180086 |
| Jan 31, 2024 | Olympus Corporation of the Americas EZDilate Fixed Wire Balloon 11-12-13. Indicated for endoscopic dilation of strictures of the esophagus in adults and adolescents (>12 years).
Model: BD-400P-1380 Open, Classified |
FGE | K180086 |
| Jan 31, 2024 | Olympus Corporation of the Americas EZDilate Fixed Wire Balloon 8.5-9.5-10.5. Indicated for endoscopic dilation of strictures of the esophagus in adults and adolescents (>12 years).
Model: BD-400P-1080 Open, Classified |
FGE | K180086 |
| Jan 31, 2024 | Olympus Corporation of the Americas EZDilate Fixed Wire Balloon 6-7-8. Indicated for endoscopic dilation of strictures of the esophagus in adults and adolescents (>12 years).
Model: BD-400P-0880 Open, Classified |
FGE | K180086 |
| Dec 1, 2023 | Wilson-Cook Medical Inc. QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-8X3-E, Order Number G22766; used to dilate strictures of the biliary tree Open, Classified |
FGE | K171223 |
| Dec 1, 2023 | Wilson-Cook Medical Inc. QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-8X3, Order Number G22656; used to dilate strictures of the biliary tree Open, Classified |
FGE | K171223 |
| Dec 1, 2023 | Wilson-Cook Medical Inc. QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-6X3-E, Order Number G22765; used to dilate strictures of the biliary tree Open, Classified |
FGE | K171223 |
| Dec 1, 2023 | Wilson-Cook Medical Inc. QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-6X3, Order Number G22655; used to dilate strictures of the biliary tree Open, Classified |
FGE | K171223 |
| Dec 1, 2023 | Wilson-Cook Medical Inc. QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-4X3, Order Number G22654; used to dilate strictures of the biliary tree Open, Classified |
FGE | K171223 |
| Dec 1, 2023 | Wilson-Cook Medical Inc. QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-10X3-E, Order Number G22667; used to dilate strictures of the biliary tree Open, Classified |
FGE | K171223 |
| Dec 1, 2023 | Wilson-Cook Medical Inc. QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-10X3, Order Number G22657; used to dilate strictures of the biliary tree Open, Classified |
FGE | K171223 |
| Oct 7, 2022 | Hobbs Medical, Inc. Freeman Pancreatic Flexi-Stent (contained in kit 6501)
Catalog Number: 6541 Open, Classified |
FGE | K834351 |
| Oct 7, 2022 | Hobbs Medical, Inc. Freeman Pancreatic Flexi-Stent
Catalog Number: 6584 Open, Classified |
FGE | K834351 |
| Oct 7, 2022 | Hobbs Medical, Inc. Freeman Pancreatic Flexi-Stent
Catalog Number: 6582 Open, Classified |
FGE | K834351 |
| Oct 7, 2022 | Hobbs Medical, Inc. Freeman Pancreatic Flexi-Stent
Catalog Number: 6568 Open, Classified |
FGE | K834351 |
| Oct 7, 2022 | Hobbs Medical, Inc. Freeman Pancreatic Flexi-Stent
Catalog Number: 6567 Open, Classified |
FGE | K834351 |
| Oct 7, 2022 | Hobbs Medical, Inc. Freeman Pancreatic Flexi-Stent
Catalog Number: 6566 Open, Classified |
FGE | K834351 |
| Oct 7, 2022 | Hobbs Medical, Inc. Freeman Pancreatic Flexi-Stent
Catalog Number: 6562 Open, Classified |
FGE | K834351 |
| Oct 7, 2022 | Hobbs Medical, Inc. Freeman Pancreatic Flexi-Stent
Catalog Number: 6548 Open, Classified |
FGE | K834351 |
| Oct 7, 2022 | Hobbs Medical, Inc. Freeman Pancreatic Flexi-Stent
Catalog Number: 6544 Open, Classified |
FGE | K834351 |
| Oct 7, 2022 | Hobbs Medical, Inc. Freeman Pancreatic Flexi-Stent
Catalog Number: 6535 Open, Classified |
FGE | K834351 |
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