K130046 is an FDA 510(k) clearance for the CLEARSPEC SINGLE USE VAGINAL SPECULUM, a Speculum, Vaginal, Nonmetal (Class II — Special Controls, product code HIB), submitted by Clearspec, LLC (Herkimer, US). The FDA issued a Cleared decision on August 6, 2013, 210 days after receiving the submission on January 8, 2013. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.4530.
| 510(k) Number | K130046 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | January 08, 2013 |
| Decision Date | August 06, 2013 |
| Days to Decision | 210 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 |