K951898 is an FDA 510(k) clearance for the VERSA-VU. This device is classified as a Speculum, Vaginal, Nonmetal (Class II - Special Controls, product code HIB).
Submitted by CooperSurgical, Inc. (Shelton, US). The FDA issued a Cleared decision on December 11, 1995, 231 days after receiving the submission on April 24, 1995.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.4530.
| 510(k) Number | K951898 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 24, 1995 |
| Decision Date | December 11, 1995 |
| Days to Decision | 231 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | HIB — Speculum, Vaginal, Nonmetal |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.4530 |