Home › Device types › FGE
Stents, Drains And Dilators For The Biliary Ducts
FDA product code FGE · Class 2 · Gastroenterology, Urology
4,819
Registered devices
33,655
Adverse events
450
Recalls
476
510(k) clearances
Devices with this code
Single Use Biliary Stent V — OLYMPUS MEDICAL SYSTEMS CORP.Visi-Pro — Covidien LPMUSTANG™ — BOSTON SCIENTIFIC CORPORATIONE·Luminexx® Biliary Stent — Bard Peripheral Vascular, Inc.Cotton-Leung — COOK IRELAND LTDMUSTANG™ — BOSTON SCIENTIFIC CORPORATIONBiliary Plastic Stent — Micro-Tech (Nanjing) Co., Ltd.MultiStage® — Dongguan TT Medical, Inc.C-Flex™ Biliary — BOSTON SCIENTIFIC CORPORATIONBREEZE® XS APD — Medical Components, Inc.ACCEL® — B BRAUN INTERVENTIONAL SYSTEMS, INCHobbs Biliary Amsterdam Stent — HOBBS MEDICAL, INC.Mardis Soft — BOSTON SCIENTIFIC CORPORATIONFusion Zilver — COOK INCORPORATEDZilver Flex 35 — COOK INCORPORATEDPALMAZ GENESIS Transhepatic Biliary Stent on OPTA PRO .035" Delivery System — Cordis US Corp.Cotton-Huibregtse — COOK IRELAND LTDOasis — COOK IRELAND LTDWallFlex™ Biliary — BOSTON SCIENTIFIC CORPORATIONZilver 635 — COOK IRELAND LTDOasis — COOK IRELAND LTDPALMAZ GENESIS Transhepatic Biliary Stent on SLALOM .018" Delivery System — CORDIS CORPORATIONSingle Use Biliary Drainage Stent V — OLYMPUS MEDICAL SYSTEMS CORP.E·Luminexx® Biliary Stent — Bard Peripheral Vascular, Inc.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-05-22 | W L Gore & Associates, Inc. | 10 mm diameter x 7 cm with transmural drainage holes (VSWVH1006) incorrectly labeled as 10 mm diameter x 10 cm length devices without transmural drainage holes |
| 2026-05-22 | W L Gore & Associates, Inc. | 10 mm diameter x 7 cm with transmural drainage holes (VSWVH1006) incorrectly labeled as 10 mm diameter x 10 cm length devices without transmural drainage holes |
| 2026-05-21 | Boston Scientific Corporation | Potential sterile breach of the pouches in which devices are packaged. |
| 2026-05-21 | Boston Scientific Corporation | Potential sterile breach of the pouches in which devices are packaged. |
| 2026-05-21 | Boston Scientific Corporation | Potential sterile breach of the pouches in which devices are packaged. |
| 2026-05-21 | Boston Scientific Corporation | Potential sterile breach of the pouches in which devices are packaged. |
| 2026-05-21 | Boston Scientific Corporation | Potential sterile breach of the pouches in which devices are packaged. |
| 2026-05-21 | Boston Scientific Corporation | Potential sterile breach of the pouches in which devices are packaged. |
| 2026-03-05 | Cook Incorporated | Products from the affected device lots were labeled with expiration dates that exceed the true shelf life. |
| 2025-08-28 | Boston Scientific Corporation | The product in incorrectly labeled. The label indicates that the skive hole should be above the balloon, while it is actually positioned below, and vice versa. |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docsSourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.