KNS — Unit, Electrosurgical, Endoscopic (With Or Without Accessories) Class II
FDA product code KNS covers "Unit, Electrosurgical, Endoscopic (With Or Without Accessories)", a Class II medical device regulated under 21 CFR 876.4300. Submissions are reviewed by the Gastroenterology, Urology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- KNS
- Device Class
- Class II
- Regulation Number
- 876.4300
- Submission Type
- Review Panel
- GU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K260962 | taewoong medical co | Sphincterotome | May 21, 2026 |
| K252388 | francis medical | Vanquish Water Vapor Ablation Device | November 26, 2025 |
| K252889 | olympus medical systems corporation | Single Use 3-Lumen Needle Knife V (KD-V441M, KD-V451M) | November 25, 2025 |
| K250945 | olympus medical systems | Single Use Preloaded Sphincterotome V (Distal Wire Guided) (KD-VC600 Series); Si | October 17, 2025 |
| K250351 | olympus medical systems corporation | Single Use Electrosurgical Knife (KD-612L, KD-612U); Single Use Electrosurgical | October 10, 2025 |
| K251104 | wilson-cook medical | SureTome SW Sphincterotome with DomeTip | September 29, 2025 |
| K251226 | aqua medical | Aqua Medical RF Vapor Ablation System | August 8, 2025 |
| K250584 | boston scientific corporation | Rezum System | June 11, 2025 |
| K242774 | creo medical | SpydrBlade Flex Instrument (PRD-RG1-001) | June 6, 2025 |
| K241855 | sb-kawasumi laboratories | SB Knife Jr2 (MD-47702 and MD-47702L) | March 26, 2025 |
| K242192 | beijing zksk technology co | Disposable Sphincterotome | February 6, 2025 |
| K243568 | wilson-cook medical | Teslatome Bipolar Sphincterotome; Tesla BiCord Active Cord | January 17, 2025 |
| K241271 | aqua medical | Aqua Medical RF Vapor Ablation System | December 12, 2024 |
| K242061 | creo medical | Reusable Interface Cable 1.5 m (PRD-IFC-002) | August 15, 2024 |
| K232825 | jiangsu vedkang medical science and technology co | Disposable Sphincterotome | March 29, 2024 |
| K232633 | boston scientific | Gold Probe Bipolar Electrohemostasis Catheter; Injection Gold Probe Bipolar Elec | November 28, 2023 |
| K232476 | zhejiang soudon medical technology co | Disposable Sphincterotome | November 7, 2023 |
| K230328 | creo medical | Speedboat Flush SB1 Instrument | October 31, 2023 |
| K233318 | boston scientific corporation | AXIOS Stent and Electrocautery-Enhanced Delivery System (6mmx8mm); AXIOS Stent a | October 27, 2023 |
| K233113 | starmed co | ELRA Electrode (7-2B11S, 7-2B11L, 7-2B22S, 7-2B22L, 7-4B18S, 7-4B18L, 7-4B33S, 7 | October 25, 2023 |