KNS · Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
Gastroenterology, Urology · 21 CFR 876.4300 · Class 2
Overview
| Product Code | KNS |
|---|---|
| Device Name | Unit, Electrosurgical, Endoscopic (With Or Without Accessories) |
| Regulation | 21 CFR 876.4300 |
| Device Class | Class 2 |
| Review Panel | Gastroenterology, Urology |
| 3rd-Party Reviewable | Yes |
Identification
An endoscopic electrosurgical unit and accessories is a device used to perform electrosurgical procedures through an endoscope. This generic type of device includes the electrosurgical generator, patient plate, electric biopsy forceps, electrode, flexible snare, electrosurgical alarm system, electrosurgical power supply unit, electrical clamp, self-opening rigid snare, flexible suction coagulator electrode, patient return wristlet, contact jelly, adaptor to the cord for transurethral surgical instruments, the electric cord for transurethral surgical instruments, and the transurethral desiccator.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (20 of 187)
Showing 20 most recent of 187 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K252388 | Vanquish Water Vapor Ablation Device | Francis Medical, Inc. | Nov 26, 2025 | SESE |
| K252889 | Single Use 3-Lumen Needle Knife V (KD-V441M, KD-V451M) | Olympus Medical Systems Corporation | Nov 25, 2025 | SESE |
| K250945 | Single Use Preloaded Sphincterotome V (Distal Wire Guided) (KD-VC600 Series); Single Use Sphincterotome V (Distal Wire Guided) (KD-VC400 Series); Single Use 3-Lumen Sphincterotome (KD-V Series); Disposable Triple Lumen Sphincterotome (KD Series) | Olympus Medical Systems Corp. | Oct 17, 2025 | SESE |
| K250351 | Single Use Electrosurgical Knife (KD-612L, KD-612U); Single Use Electrosurgical Knife (KD-620UR); Single Use Electrosurgical Knife (KD-650L, KD-650U) | Olympus Medical Systems Corporation | Oct 10, 2025 | SESE |
| K251104 | SureTome SW Sphincterotome with DomeTip | Wilson-Cook Medical | Sep 29, 2025 | SESE |
| K251226 | Aqua Medical RF Vapor Ablation System | Aqua Medical, Inc. | Aug 8, 2025 | SESE |
| K250584 | Rezum System | Boston Scientific Corporation | Jun 11, 2025 | SESE |
| K242774 | SpydrBlade Flex Instrument (PRD-RG1-001) | Creo Medical, Ltd. | Jun 6, 2025 | SESE |
| K241855 | SB Knife Jr2 (MD-47702 and MD-47702L) | Sb-Kawasumi Laboratories, Inc. | Mar 26, 2025 | SESE |
| K242192 | Disposable Sphincterotome | Beijing Zksk Technology Co., Ltd. | Feb 6, 2025 | SESE |
| K243568 | Teslatome Bipolar Sphincterotome; Tesla BiCord Active Cord | Wilson-Cook Medical, Inc. | Jan 17, 2025 | SESE |
| K241271 | Aqua Medical RF Vapor Ablation System | Aqua Medical, Inc. | Dec 12, 2024 | SESE |
| K242061 | Reusable Interface Cable 1.5 m (PRD-IFC-002) | Creo Medical, Ltd. | Aug 15, 2024 | SESE |
| K232825 | Disposable Sphincterotome | Jiangsu Vedkang Medical Science and Technology Co., Ltd. | Mar 29, 2024 | SESE |
| K232633 | Gold Probe Bipolar Electrohemostasis Catheter; Injection Gold Probe Bipolar Electrohemostasis Catheter | Boston Scientific | Nov 28, 2023 | SESE |
| K232476 | Disposable Sphincterotome | Zhejiang Soudon Medical Technology Co., Ltd. | Nov 7, 2023 | SESE |
| K230328 | Speedboat Flush SB1 Instrument | Creo Medical, Ltd. | Oct 31, 2023 | SESE |
| K233318 | AXIOS Stent and Electrocautery-Enhanced Delivery System (6mmx8mm); AXIOS Stent and Electrocautery-Enhanced Delivery System (8mmx8mm); AXIOS Stent and Electrocautery-Enhanced Delivery System (10mmx10mm); AXIOS Stent and Electrocautery-Enhanced Delivery System (15mmx10mm); AXIOS Stent and Electrocautery-Enhanced Delivery System (20mmx10mm); AXIOS Stent and Electrocautery-Enhanced Delivery System (15mmx15mm) | Boston Scientific Corporation | Oct 27, 2023 | SESE |
| K233113 | ELRA Electrode (7-2B11S, 7-2B11L, 7-2B22S, 7-2B22L, 7-4B18S, 7-4B18L, 7-4B33S, 7-4B33L) | Starmed Co., Ltd. | Oct 25, 2023 | SESE |
| K232162 | Autotome Pro RX 39 Sphincterotome; Autotome Pro RX 44 Sphincterotome; Jagtome Pro RX 44 Sphincterotome; Jagtome Pro RX 39 Sphincterotome; Dreamtome Pro RX 44 Sphincterotome; Hydratome Pro RX 44 Sphincterotome; Jagtome Revolution Pro RX 39 Sphincterotome | Boston Scientific Corporation | Aug 14, 2023 | SESE |
Top Applicants
- Wilson-Cook Medical, Inc. — 11 clearances
- Boston Scientific Corp — 9 clearances
- Olympus Medical Systems Corp. — 7 clearances
- Boston Scientific Corporation — 7 clearances
- Mr Associates, Inc. — 5 clearances
