K910254 is an FDA 510(k) clearance for the DIAGNOSTIC HYSTEROSCOPY REDIKIT (TM). This device is classified as a Cup, Menstrual (Class II - Special Controls, product code HHE).
Submitted by CooperSurgical, Inc. (Mountain View, US). The FDA issued a Cleared decision on April 18, 1991, 86 days after receiving the submission on January 22, 1991.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.5400. A Menstrual Cup Is A Receptacle Placed In The Vagina To Collect Menstrual Flow..
| 510(k) Number | K910254 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Direct De Novo (SESD) |
| Date Received | January 22, 1991 |
| Decision Date | April 18, 1991 |
| Days to Decision | 86 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | — |
| Product Code | HHE — Cup, Menstrual |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.5400 |
| Definition | A Menstrual Cup Is A Receptacle Placed In The Vagina To Collect Menstrual Flow. |