K052314 is an FDA 510(k) clearance for the DYNAREX VAGINAL SPECULA 4900, MODELS 4911-SMALL, 4912-MEDIUM, 4913-LARGE, a Speculum, Vaginal, Nonmetal (Class II — Special Controls, product code HIB), submitted by Dynarex Corp. (Orangeburg, US). The FDA issued a Cleared decision on November 9, 2005, 76 days after receiving the submission on August 25, 2005. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.4530.
| 510(k) Number | K052314 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 25, 2005 |
| Decision Date | November 09, 2005 |
| Days to Decision | 76 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 |