FGE
- Product code
- FGE
- Device name
- Stents, Drains And Dilators For The Biliary Ducts
- Device class
- Class 2
- 21 CFR
- 21 CFR 876.5010
- Medical specialty
- Gastroenterology, Urology
- Marketing pathway
- 510(K)
- Flag
- Implant
- Flag
- Life-sustaining / life-supporting
- 510(k) clearances (last 3 years)
- 21
- Summaries archived here
- 19 (direct download)
- 510(k) clearances (all years, FDA)
- 476 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (21)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K260835 | 2026-07-27 | Q3 Medical USA, LLC (C/O Q3 Medical De… | ARCHIMEDES Biodegradable Stent (Medium) | |
| K253393 | 2026-06-24 | Hangzhou AGS MedTech Co., Ltd. | Single-use Balloon Dilatation Catheter (AG-5251-0830… | |
| K253832 | 2026-04-24 | Mirco-Tech (Nanjing) Co., Ltd. | Dilation Balloon Catheter | |
| K251658 | 2026-04-16 | Medi-Globe GmbH | Endoflux Biliary & Pancreatic Stent Sets | |
| K253987 | 2026-03-13 | GIE Medical | BARE Wireguided Balloon Dilation Catheter (1235) | |
| K253132 | 2026-03-06 | Zhejiang Chuangxiang Medical Technolog… | Single use stone retrieval balloons | |
| K251123 | 2025-12-29 | Taewoong Medical Co., Ltd. | Niti-S Biliary Stent; Niti-S Biliary Slim M Stent | |
| K251019 | 2025-12-22 | Bioteque Corporation | BIOTEQ Drainage Catheter Set: BT-PD1-SERIES-G and BT… | |
| K250409 | 2025-10-21 | Olympus Medical Systems Corporation | Disposable Balloon Catheter (B5-2Q); Disposable Bal… | |
| K251229 | 2025-08-20 | Softac Medical Technologies | EndoFixTissue Fixation System | |
| K243412 | 2025-07-16 | Q3 Medical USA, LLC (C/O Q3 Medical De… | ARCHIMEDES Biodegradable Pancreatic Stent | FDA |
| K251291 | 2025-07-03 | Boston Scientific | Advanix Pancreatic Stent and NaviFlex Rapid Exchan… | |
| K242845 | 2025-06-25 | S&G Biotech, Inc. | EGIS Biliary Double Bare Stent (BDB080405) | |
| K241888 | 2024-12-20 | Leo Medical Co., Ltd. | Single-use Balloon Dilatation Catheter | FDA |
| K241801 | 2024-12-17 | Asahi Intecc Co., Ltd. | Tornus ES | |
| K242950 | 2024-12-06 | Boston Scientific | WallFlex Biliary PLUS RX Stent System | |
| K240464 | 2024-08-30 | Boston Scientific | WallFlex Biliary RX Stent System; Epic Biliary Stent… | |
| K233079 | 2024-06-14 | Cook Ireland, Ltd. | Zimmon® Pancreatic Stents/Stent sets (SPSOF, SPSOS, … | |
| K232245 | 2024-02-15 | Jiangsu Vedkang Medical Science and Te… | VedDilator ^TM (3-Stage Balloon Dilation Catheter) | |
| K232596 | 2023-09-27 | Endogi Medical, Ltd. | EndoGI S-Path Biliary Stent System | |
| K223354 | 2023-09-21 | S&G Biotech, Inc. | EGIS Biliary Single Bare Stent |
Official FDA classification page: FGE
Classification and pathway per current FDA publications. Data from openFDA (CC0).