KNS
- 产品代码
- KNS
- 器械名称
- Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
- 管理类别
- 第 2 类（Class II）
- 21 CFR 条款
- 21 CFR 876.4300
- FDA 专业组
- Gastroenterology, Urology
- 上市路径
- 需提交 510(k) 上市前通告
- 标记
- 可走第三方审查
- 该代码近三年的 510(k)
- 20 件
- 其中 Summary 已存档
- 18 份，可直接下载
- FDA 历史累计 510(k)
- 188 件（全部年份；本站只收录近三年的明细）
该代码近三年的 510(k)（20 件）
| 510(k) 号 | 批准日期 | 申请人 | 器械名称 | 摘要 |
|---|---|---|---|---|
| K260962 | 2026-05-21 | Taewoong Medical Co., Ltd. | Sphincterotome | FDA |
| K252388 | 2025-11-26 | Francis Medical, Inc. | Vanquish Water Vapor Ablation Device | |
| K252889 | 2025-11-25 | Olympus Medical Systems Corporation | Single Use 3-Lumen Needle Knife V (KD-V441M, KD-V451… | |
| K250945 | 2025-10-17 | Olympus Medical Systems Corp. | Single Use Preloaded Sphincterotome V (Distal Wire G… | |
| K250351 | 2025-10-10 | Olympus Medical Systems Corporation | Single Use Electrosurgical Knife (KD-612L, KD-612U);… | |
| K251104 | 2025-09-29 | Wilson-Cook Medical | SureTome SW Sphincterotome with DomeTip | |
| K251226 | 2025-08-08 | Aqua Medical, Inc. | Aqua Medical RF Vapor Ablation System | |
| K250584 | 2025-06-11 | Boston Scientific Corporation | Rezum System | FDA |
| K242774 | 2025-06-06 | Creo Medical, Ltd. | SpydrBlade Flex Instrument (PRD-RG1-001) | |
| K241855 | 2025-03-26 | Sb-Kawasumi Laboratories, Inc. | SB Knife Jr2 (MD-47702 and MD-47702L) | |
| K242192 | 2025-02-06 | Beijing Zksk Technology Co., Ltd. | Disposable Sphincterotome | |
| K243568 | 2025-01-17 | Wilson-Cook Medical, Inc. | Teslatome Bipolar Sphincterotome; Tesla BiCord Activ… | |
| K241271 | 2024-12-12 | Aqua Medical, Inc. | Aqua Medical RF Vapor Ablation System | |
| K242061 | 2024-08-15 | Creo Medical, Ltd. | Reusable Interface Cable 1.5 m (PRD-IFC-002) | |
| K232825 | 2024-03-29 | Jiangsu Vedkang Medical Science and Te… | Disposable Sphincterotome | |
| K232633 | 2023-11-28 | Boston Scientific | Gold Probe Bipolar Electrohemostasis Catheter; Injec… | |
| K232476 | 2023-11-07 | Zhejiang Soudon Medical Technology Co.… | Disposable Sphincterotome | |
| K230328 | 2023-10-31 | Creo Medical, Ltd. | Speedboat Flush SB1 Instrument | |
| K233318 | 2023-10-27 | Boston Scientific Corporation | AXIOS Stent and Electrocautery-Enhanced Delivery Sys… | |
| K233113 | 2023-10-25 | Starmed Co., Ltd. | ELRA Electrode (7-2B11S, 7-2B11L, 7-2B22S, 7-2B22L, … |
FDA 官方分类页： KNS
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。