FGE
- 产品代码
- FGE
- 器械名称
- Stents, Drains And Dilators For The Biliary Ducts
- 管理类别
- 第 2 类（Class II）
- 21 CFR 条款
- 21 CFR 876.5010
- FDA 专业组
- Gastroenterology, Urology
- 上市路径
- 需提交 510(k) 上市前通告
- 标记
- 属植入器械
- 标记
- 属生命支持/维持器械
- 该代码近三年的 510(k)
- 476 件
该代码近三年的 510(k)（21 件）
| 510(k) 号 | 批准日期 | 申请人 | 器械名称 |
|---|---|---|---|
| K260835 | 2026-07-27 | Q3 Medical USA, LLC (C/O Q3 Medical De | ARCHIMEDES Biodegradable Stent (Medium) 摘要 |
| K253393 | 2026-06-24 | Hangzhou AGS MedTech Co., Ltd. | Single-use Balloon Dilatation Catheter (AG-5251-0830 摘要 |
| K253832 | 2026-04-24 | Mirco-Tech (Nanjing) Co., Ltd. | Dilation Balloon Catheter 摘要 |
| K251658 | 2026-04-16 | Medi-Globe GmbH | Endoflux Biliary & Pancreatic Stent Sets 摘要 |
| K253987 | 2026-03-13 | GIE Medical | BARE Wireguided Balloon Dilation Catheter (1235) 摘要 |
| K253132 | 2026-03-06 | Zhejiang Chuangxiang Medical Technolog | Single use stone retrieval balloons 摘要 |
| K251123 | 2025-12-29 | Taewoong Medical Co., Ltd. | Niti-S Biliary Stent; Niti-S Biliary Slim M Stent 摘要 |
| K251019 | 2025-12-22 | Bioteque Corporation | BIOTEQ Drainage Catheter Set: BT-PD1-SERIES-G and BT 摘要 |
| K250409 | 2025-10-21 | Olympus Medical Systems Corporation | Disposable Balloon Catheter (B5-2Q); Disposable Bal 摘要 |
| K251229 | 2025-08-20 | Softac Medical Technologies | EndoFixTissue Fixation System 摘要 |
| K243412 | 2025-07-16 | Q3 Medical USA, LLC (C/O Q3 Medical De | ARCHIMEDES Biodegradable Pancreatic Stent 摘要 |
| K251291 | 2025-07-03 | Boston Scientific | Advanix Pancreatic Stent and NaviFlex Rapid Exchan 摘要 |
| K242845 | 2025-06-25 | S&G Biotech, Inc. | EGIS Biliary Double Bare Stent (BDB080405) 摘要 |
| K241888 | 2024-12-20 | Leo Medical Co., Ltd. | Single-use Balloon Dilatation Catheter 摘要 |
| K241801 | 2024-12-17 | Asahi Intecc Co., Ltd. | Tornus ES 摘要 |
| K242950 | 2024-12-06 | Boston Scientific | WallFlex Biliary PLUS RX Stent System 摘要 |
| K240464 | 2024-08-30 | Boston Scientific | WallFlex Biliary RX Stent System; Epic Biliary Stent 摘要 |
| K233079 | 2024-06-14 | Cook Ireland, Ltd. | Zimmon® Pancreatic Stents/Stent sets (SPSOF, SPSOS, 摘要 |
| K232245 | 2024-02-15 | Jiangsu Vedkang Medical Science and Te | VedDilator ^TM (3-Stage Balloon Dilation Catheter) 摘要 |
| K232596 | 2023-09-27 | Endogi Medical, Ltd. | EndoGI S-Path Biliary Stent System 摘要 |
| K223354 | 2023-09-21 | S&G Biotech, Inc. | EGIS Biliary Single Bare Stent 摘要 |
FDA 官方分类页： FGE
分类与上市路径以 FDA 现行公告为准。本页数据来自 openFDA（CC0 公有领域），不构成注册策略建议。