K925114 is an FDA 510(k) clearance for the LAPAROSCOPIC INSTRUMENTS, a Coagulator, Culdoscopic (and Accessories) (Class II — Special Controls, product code HFI), submitted by Endo Technic Corp. (Northbrook, US). The FDA issued a Cleared decision on February 28, 1994, 507 days after receiving the submission on October 9, 1992. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.4160.
| 510(k) Number | K925114 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | October 09, 1992 |
| Decision Date | February 28, 1994 |
| Days to Decision | 507 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 |