K925079 is an FDA 510(k) clearance for the LAPAROSCOPIC INST. (SCISSORS,FORCEPS,NEEDLEHOLDER), a Laparoscope, Gynecologic (and Accessories) (Class II — Special Controls, product code HET), submitted by Endo Technic Corp. (Northbrook, US). The FDA issued a Cleared decision on August 24, 1994, 686 days after receiving the submission on October 7, 1992. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.1720.
| 510(k) Number | K925079 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | October 07, 1992 |
| Decision Date | August 24, 1994 |
| Days to Decision | 686 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | HET — Laparoscope, Gynecologic (and Accessories) |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 884.1720 |