K965055 is an FDA 510(k) clearance for the IMAGYN MICROLAP AND MICRO LAP-GOLD LAPAROSCOPES, a Laparoscope, Gynecologic (and Accessories) (Class II — Special Controls, product code HET), submitted by Imagyn Medical, Inc. (Laguna Niguel, US). The FDA issued a Cleared decision on March 6, 1997, 78 days after receiving the submission on December 18, 1996. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.1720.
| 510(k) Number | K965055 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | December 18, 1996 |
| Decision Date | March 06, 1997 |
| Days to Decision | 78 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 |