K133857 is an FDA 510(k) clearance for the BRELLA-SPEC(TM) VAGINAL SPECULUM, a Speculum, Vaginal, Nonmetal (Class II — Special Controls, product code HIB), submitted by Proa Medical, Inc. (Redondo Beach, US). The FDA issued a Cleared decision on April 28, 2014, 130 days after receiving the submission on December 19, 2013. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.4530.
| 510(k) Number | K133857 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | December 19, 2013 |
| Decision Date | April 28, 2014 |
| Days to Decision | 130 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 |