K915406 is an FDA 510(k) clearance for the DAVOL ELECTROSUGICAL PROBES, a Coagulator, Laparoscopic, Unipolar (and Accessories) (Class II — Special Controls, product code HFG), submitted by Davol, Inc. (Cranston, US). The FDA issued a Cleared decision on February 28, 1992, 88 days after receiving the submission on December 2, 1991. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.4160.
| 510(k) Number | K915406 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | December 02, 1991 |
| Decision Date | February 28, 1992 |
| Days to Decision | 88 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | HFG — Coagulator, Laparoscopic, Unipolar (and Accessories) |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 884.4160 |