K242192 is an FDA 510(k) clearance for the Disposable Sphincterotome, a Unit, Electrosurgical, Endoscopic (with Or Without Accessories) (Class II — Special Controls, product code KNS), submitted by Beijing Zksk Technology Co., Ltd. (Beijing, CN). The FDA issued a Cleared decision on February 6, 2025, 195 days after receiving the submission on July 26, 2024. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.4300.
| 510(k) Number | K242192 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | July 26, 2024 |
| Decision Date | February 06, 2025 |
| Days to Decision | 195 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 |