K910253 is an FDA 510(k) clearance for the LEEP REDIKIT. This device is classified as a Set, Anesthesia, Paracervical (Class II - Special Controls, product code HEE).
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 884.5100.
| 510(k) Number | K910253 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| 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 | HEE — Set, Anesthesia, Paracervical |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.5100 |