K250945 is an FDA 510(k) clearance for the Single Use Preloaded Sphincterotome V (Distal Wire Guided) (KD-VC600 Series). This device is classified as a Unit, Electrosurgical, Endoscopic (with Or Without Accessories) (Class II - Special Controls, product code KNS).
Submitted by Olympus Medical Systems Corp. (Hachioji-Shi, JP). The FDA issued a Cleared decision on October 17, 2025, 203 days after receiving the submission on March 28, 2025.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.4300.
| 510(k) Number | K250945 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 28, 2025 |
| Decision Date | October 17, 2025 |
| Days to Decision | 203 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | KNS — Unit, Electrosurgical, Endoscopic (with Or Without Accessories) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.4300 |