K951600 is an FDA 510(k) clearance for the MILL-ROSE ROTATABLE POLYPECTOMY SNARE, a Snare, Flexible (Class II — Special Controls, product code FDI), submitted by Mill-Rose Laboratory (Mentor, US). The FDA issued a Cleared decision on December 18, 1995, 255 days after receiving the submission on April 7, 1995. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.4300.
| 510(k) Number | K951600 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | April 07, 1995 |
| Decision Date | December 18, 1995 |
| Days to Decision | 255 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | FDI — Snare, Flexible |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 876.4300 |