K924148 is an FDA 510(k) clearance for the DIAMOND-SHARP(R) TROCARS, a Coagulator, Culdoscopic (and Accessories) (Class II — Special Controls, product code HFI), submitted by Snowden-Pencer (Tucker, US). The FDA issued a Cleared decision on February 28, 1994, 559 days after receiving the submission on August 18, 1992. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.4160.
| 510(k) Number | K924148 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 18, 1992 |
| Decision Date | February 28, 1994 |
| Days to Decision | 559 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 |