Device type
Stents, Drains And Dilators For The Biliary Ducts
Product code FGE · Class II · 21 CFR 876.5010 · Gastroenterology, Urology
Recent 510(k)s
Sep 18, 2026
K254179
Drainage Catheter
Canyon Medical, Inc.
- FGE
- Class II
Sep 17, 2026
K262913
Protégé™ EverFlex™ Self-expanding Peripheral Stent System
Medtronic, Inc.
- FGE
- Class II
Recent recalls
Oct 21, 2026
Z-0143-2027
NaviFlex LW Pusher; Advx Panc. Stent 4/5F; Material Number (UPN): M00535030;
Boston Scientific Corporation
- FGE
- Class II
- Ongoing
Oct 21, 2026
Z-0158-2027
Generic Name: GORE VIABIL Short Wire Biliary Endoprosthesis; Model/Catalog Number: VSWVH0808 and VSWVN1006 Product Description: The GORE VIABIL Short Wire Bili…
W L Gore & Associates, Inc.
- FGE
- Class II
- Ongoing
Sep 30, 2026
Z-3216-2026
Olympus EZDilate Endoscopic Balloon Dilator Wired-guided 11, 12, 13mm. Model Number: BD-420X-1355.
Olympus Corporation of the Americas
- FGE
- Class II
- Ongoing