FGE — Stents, Drains And Dilators For The Biliary Ducts Class II
FDA product code FGE covers "Stents, Drains And Dilators For The Biliary Ducts", a Class II medical device regulated under 21 CFR 876.5010. Submissions are reviewed by the Gastroenterology, Urology panel. Devices under this code are implants. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- FGE
- Device Class
- Class II
- Regulation Number
- 876.5010
- Submission Type
- Review Panel
- GU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- Yes
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K253393 | hangzhou ags medtech co | Single-use Balloon Dilatation Catheter (AG-5251-083018 AG-5251-085518 AG-5251-08 | June 24, 2026 |
| K253832 | mirco-tech (nanjing) co | Dilation Balloon Catheter | April 24, 2026 |
| K251658 | medi-globe | Endoflux Biliary & Pancreatic Stent Sets | April 16, 2026 |
| K253987 | gie medical | BARE Wireguided Balloon Dilation Catheter (1235) | March 13, 2026 |
| K253132 | zhejiang chuangxiang medical technology co | Single use stone retrieval balloons | March 6, 2026 |
| K251123 | taewoong medical co | Niti-S Biliary Stent; Niti-S Biliary Slim M Stent | December 29, 2025 |
| K251019 | bioteque corporation | BIOTEQ Drainage Catheter Set: BT-PD1-SERIES-G and BT-PDS-SERIES-G | December 22, 2025 |
| K250409 | olympus medical systems corporation | Disposable Balloon Catheter (B5-2Q); Disposable Balloon Catheter (B7-2Q); Disp | October 21, 2025 |
| K251229 | softac medical technologies | EndoFixTissue Fixation System | August 20, 2025 |
| K243412 | q3 medical usa, llc (c/o q3 medical devices ltd.) | ARCHIMEDES Biodegradable Pancreatic Stent | July 16, 2025 |
| K251291 | boston scientific | Advanix Pancreatic Stent and NaviFlex Rapid Exchange (RX) Pancreatic Delivery | July 3, 2025 |
| K242845 | s and g biotech | EGIS Biliary Double Bare Stent (BDB080405) | June 25, 2025 |
| K241888 | leo medical co | Single-use Balloon Dilatation Catheter | December 20, 2024 |
| K241801 | asahi intecc co | Tornus ES | December 17, 2024 |
| K242950 | boston scientific | WallFlex Biliary PLUS RX Stent System | December 6, 2024 |
| K240464 | boston scientific | WallFlex Biliary RX Stent System; Epic Biliary Stent System; WallFlex Biliary RX | August 30, 2024 |
| K233079 | cook ireland | Zimmon® Pancreatic Stents/Stent sets (SPSOF, SPSOS, ZEPDF, ZEPDS, ZPSOF, ZPSOS); | June 14, 2024 |
| K232245 | jiangsu vedkang medical science and technology co | VedDilator ^TM (3-Stage Balloon Dilation Catheter) | February 15, 2024 |
| K232596 | endogi medical | EndoGI S-Path Biliary Stent System | September 27, 2023 |
| K223354 | s and g biotech | EGIS Biliary Single Bare Stent | September 21, 2023 |