K930571 is an FDA 510(k) clearance for the REUSABLE HANDLE FOR LAPAROSCOPIC INST. W/ROTATING, a Coagulator, Culdoscopic (and Accessories) (Class II — Special Controls, product code HFI), submitted by Numed Technologies, Inc. (Independence, US). The FDA issued a Cleared decision on February 1, 1994, 362 days after receiving the submission on February 4, 1993. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.4160.
| 510(k) Number | K930571 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | February 04, 1993 |
| Decision Date | February 01, 1994 |
| Days to Decision | 362 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Statement |
| Product Code | HFI — Coagulator, Culdoscopic (and Accessories) |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 884.4160 |