K936026 is an FDA 510(k) clearance for the COOK LAPAROSCOPIC MINI RETRACTOR SET, a Coagulator, Culdoscopic (and Accessories) (Class II — Special Controls, product code HFI), submitted by Cook Urological, Inc. (Spencer, US). The FDA issued a Cleared decision on March 11, 1994, 84 days after receiving the submission on December 17, 1993. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.4160.
| 510(k) Number | K936026 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | December 17, 1993 |
| Decision Date | March 11, 1994 |
| Days to Decision | 84 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | HFI — Coagulator, Culdoscopic (and Accessories) |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 884.4160 |