FGE · Stents, Drains And Dilators For The Biliary Ducts
Gastroenterology, Urology · 21 CFR 876.5010 · Class 2
Overview
| Product Code | FGE |
|---|---|
| Device Name | Stents, Drains And Dilators For The Biliary Ducts |
| Regulation | 21 CFR 876.5010 |
| Device Class | Class 2 |
| Review Panel | Gastroenterology, Urology |
| Implant | Yes |
| Life-Sustaining | Yes |
Identification
A biliary catheter and accessories is a tubular flexible device used for temporary or prolonged drainage of the biliary tract, for splinting of the bile duct during healing, or for preventing stricture of the bile duct. This generic type of device may include a bile collecting bag that is attached to the biliary catheter by a connector and fastened to the patient with a strap.
Classification Rationale
Class II (special controls). The device, when it is a bile collecting bag or a surgical biliary catheter that does not include a balloon component, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.
Special Controls
*Classification.* Class II (special controls). The device, when it is a bile collecting bag or a surgical biliary catheter that does not include a balloon component, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.
Recent Cleared Devices (20 of 475)
Showing 20 most recent of 475 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K253393 | Single-use Balloon Dilatation Catheter (AG-5251-083018 AG-5251-085518 AG-5251-088018 AG-5251-083019 AG-5251-085519 AG-5251-088019 AG-5251-083021 AG-5251-085521 AG-5251-088021 AG-5251-083024 AG-5251-085524 AG-5251-088024 AG-5251-103018 AG-5251-105518 AG-5251-108018 AG-5251-103019 AG-5251-105519 AG-5251-108019 AG-5251-103021 AG-5251-105521 AG-5251-108021 AG-5251-103024 AG-5251-105524 AG-5251-108024 AG-5251-123018 AG-5251-125518 AG-5251-128018 AG-5251-123019 AG-5251-125519 AG-5251-128019 | Hangzhou AGS MedTech Co., Ltd. | Jun 24, 2026 | SESE |
| K253832 | Dilation Balloon Catheter | Mirco-Tech (Nanjing) Co., Ltd. | Apr 24, 2026 | SESE |
| K251658 | Endoflux™ Biliary & Pancreatic Stent Sets | Medi-Globe GmbH | Apr 16, 2026 | SESE |
| K253987 | BARE Wireguided Balloon Dilation Catheter (1235) | GIE Medical | Mar 13, 2026 | SESE |
| K253132 | Single use stone retrieval balloons | Zhejiang Chuangxiang Medical Technology Co., Ltd. | Mar 6, 2026 | SESE |
| K251123 | Niti-S Biliary Stent; Niti-S Biliary Slim M Stent | Taewoong Medical Co., Ltd. | Dec 29, 2025 | SESU |
| K251019 | BIOTEQ Drainage Catheter Set: BT-PD1-SERIES-G and BT-PDS-SERIES-G | Bioteque Corporation | Dec 22, 2025 | SESE |
| K250409 | Disposable Balloon Catheter (B5-2Q); Disposable Balloon Catheter (B7-2Q); Disposable Balloon Catheter (B7-2LA) | Olympus Medical Systems Corporation | Oct 21, 2025 | SESE |
| K251229 | EndoFix™Tissue Fixation System | Softac Medical Technologies | Aug 20, 2025 | SESE |
| K243412 | ARCHIMEDES Biodegradable Pancreatic Stent | Q3 Medical USA, LLC (C/O Q3 Medical Devices Ltd.) | Jul 16, 2025 | SESE |
| K251291 | Advanix™ Pancreatic Stent and NaviFlex™ Rapid Exchange (RX) Pancreatic Delivery System and Pushers | Boston Scientific | Jul 3, 2025 | SESE |
| K242845 | EGIS Biliary Double Bare Stent (BDB080405) | S&G Biotech, Inc. | Jun 25, 2025 | SESU |
| K241888 | Single-use Balloon Dilatation Catheter | Leo Medical Co., Ltd. | Dec 20, 2024 | SESE |
| K241801 | Tornus ES | Asahi Intecc Co., Ltd. | Dec 17, 2024 | SESE |
| K242950 | WallFlex Biliary PLUS RX Stent System | Boston Scientific | Dec 6, 2024 | SESU |
| K240464 | WallFlex Biliary RX Stent System; Epic Biliary Stent System; WallFlex Biliary RX Fully Covered Stent System RMV | Boston Scientific | Aug 30, 2024 | SESU |
| K233079 | Zimmon® Pancreatic Stents/Stent sets (SPSOF, SPSOS, ZEPDF, ZEPDS, ZPSOF, ZPSOS); Geenen® Pancreatic Stents/Stent Sets (GEPD, GPDS, GPSO, GPSOS); Johlin® Pancreatic Wedge Stent and Introducer Set (JPWS); Pushing Catheter and Guiding Catheter (GC, PC); Geenen® Sof-Flex® Pancreatic Stent (GPSO-SF. GPSOS-SF) | Cook Ireland, Ltd. | Jun 14, 2024 | SESE |
| K232245 | VedDilator ^TM (3-Stage Balloon Dilation Catheter) | Jiangsu Vedkang Medical Science and Technology Co., Ltd. | Feb 15, 2024 | SESE |
| K232596 | EndoGI S-Path Biliary Stent System | Endogi Medical, Ltd. | Sep 27, 2023 | SESU |
| K223354 | EGIS Biliary Single Bare Stent | S&G Biotech, Inc. | Sep 21, 2023 | SESU |
Top Applicants
- Cordis Corp. — 37 clearances
- Boston Scientific Corp — 35 clearances
- Cook, Inc. — 20 clearances
- Wilson-Cook Medical, Inc. — 20 clearances
- Guidant Corp. — 17 clearances
