K092421 is an FDA 510(k) clearance for the ALPHAHYSTEROSCOPE, FIBEROPTIC, OPERATIVE AND DIAGNOSTIC, a Hysteroscope (and Accessories) (Class II — Special Controls, product code HIH), submitted by Gimmi GmbH (Saint Paul, US). The FDA issued a Cleared decision on February 12, 2010, 189 days after receiving the submission on August 7, 2009. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.1690.
| 510(k) Number | K092421 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 07, 2009 |
| Decision Date | February 12, 2010 |
| Days to Decision | 189 days |
| Submission Type | Abbreviated |
| 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 |