KNS
- Product code
- KNS
- Device name
- Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
- Device class
- Class 2
- 21 CFR
- 21 CFR 876.4300
- Medical specialty
- Gastroenterology, Urology
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 20
- Summaries archived here
- 18 (direct download)
- 510(k) clearances (all years, FDA)
- 188 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (20)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| 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, … |
Official FDA classification page: KNS
Classification and pathway per current FDA publications. Data from openFDA (CC0).