K963580 is an FDA 510(k) clearance for the IMAGYN FALLOPOSCOPY SYSTEM, a Falloposcope (Class II — Special Controls, product code MKO), submitted by Imagyn Medical, Inc. (Laguna Niguel, US). The FDA issued a Cleared decision on January 31, 1997, 147 days after receiving the submission on September 6, 1996. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.1690.
| 510(k) Number | K963580 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 06, 1996 |
| Decision Date | January 31, 1997 |
| Days to Decision | 147 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | MKO — Falloposcope |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 884.1690 |