K972426 is an FDA 510(k) clearance for the MICROSPAN GOLD HYSTEROSCOPE AND MICROSPAN HYSTEROSCOPE SHEATH, a Hysteroscope (and Accessories) (Class II — Special Controls, product code HIH), submitted by Imagyn Medical, Inc. (Laguna Niguel, US). The FDA issued a Cleared decision on September 23, 1997, 88 days after receiving the submission on June 27, 1997. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.1690.
| 510(k) Number | K972426 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | June 27, 1997 |
| Decision Date | September 23, 1997 |
| Days to Decision | 88 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | HIH — Hysteroscope (and Accessories) |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 884.1690 |