Sphincterotome
FDA 510(k) K260962 · Taewoong Medical Co., Ltd.
510(k) numberK260962
Submission
- Device name
- Sphincterotome
- Applicant
- Taewoong Medical Co., Ltd.
Gimpo-Si, KR - Received
- March 23, 2026
- Decision date
- May 21, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KNS – Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.4300
- Specialty
- Gastroenterology, Urology
Other 510(k)s with product code KNS
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K262460 | Rezum SystemKNS · Traditional | Boston Scientific | 09/03/2026SE |
| K252388 | Vanquish Water Vapor Ablation DeviceKNS · Traditional | Francis Medical, Inc. | 11/26/2025SE |
| K252889 | Single Use 3-Lumen Needle Knife V (KD-V441M, KD-V451M)KNS · Traditional | Olympus Medical Systems Corporation | 11/25/2025SE |
| K250945 | Single Use Preloaded Sphincterotome V (Distal Wire Guided) (KD-VC600 Series); Single Use…KNS · Traditional | Olympus Medical Systems Corp. | 10/17/2025SE |
| K250351 | Single Use Electrosurgical Knife (KD-612L, KD-612U); Single Use Electrosurgical Knife…KNS · Traditional | Olympus Medical Systems Corporation | 10/10/2025SE |
| K251104 | SureTome SW Sphincterotome with DomeTipKNS · Traditional | Wilson-Cook Medical | 09/29/2025SE |
| K251226 | Aqua Medical RF Vapor Ablation SystemKNS · Traditional | Aqua Medical, Inc. | 08/08/2025SE |
| K250584 | Rezum SystemKNS · Traditional | Boston Scientific Corporation | 06/11/2025SE |
| K242774 | SpydrBlade Flex Instrument (PRD-RG1-001)KNS · Traditional | Creo Medical, Ltd. | 06/06/2025SE |
| K241855 | SB Knife Jr2 (MD-47702 and MD-47702L)KNS · Traditional | Sb-Kawasumi Laboratories, Inc. | 03/26/2025SE |
More from Sb-Kawasumi Laboratories, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K252648 | Niti-S SPAXUS StentPCU · Traditional | 03/13/2026SE |
| K251123 | Niti-S Biliary Stent; Niti-S Biliary Slim M StentFGE · Traditional | 12/29/2025SESU |
| K243619 | Niti-S Esophageal Stent; Esophageal TTS StentESW · Traditional | 10/30/2025SE |
| K250663 | Niti-S Duodenal Comfort Stent, Niti-S Colonic Comfort StentMUM · Special | 03/31/2025SE |
| K240522 | Esophageal TTS StentESW · Special | 03/22/2024SE |
| K223067 | Niti-S Duodenal Stent; Niti-S Colonic Comfort StentMUM · Traditional | 06/14/2023SE |
| K223626 | Niti-S Biliary Speed D StentFGE · Traditional | 05/26/2023SESU |
| K223256 | Optimos CystotomeKNS · Traditional | 04/05/2023SE |
| K221482 | Esophageal TTS StentESW · Special | 06/22/2022SE |
| K221071 | Niti-S Biliary Slim M StentFGE · Traditional | 06/09/2022SESU |
Questions and answers
When was Sphincterotome cleared by the FDA?
Sphincterotome (K260962) received a 510(k) decision of Substantially Equivalent on May 21, 2026, 59 days after the submission was received.
What is the product code of K260962?
The FDA product code is KNS – Unit, Electrosurgical, Endoscopic (With Or Without Accessories), a Class II (moderate risk) device regulated under 21 CFR 876.4300.