K132668 is an FDA 510(k) clearance for the IOB DISPOSABLE SPECULUM. This device is classified as a Speculum, Vaginal, Nonmetal (Class II - Special Controls, product code HIB).
Submitted by Iob Medical, Inc. (Gaithersburg, US). The FDA issued a Cleared decision on January 17, 2014, 143 days after receiving the submission on August 27, 2013.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.4530.
| 510(k) Number | K132668 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 27, 2013 |
| Decision Date | January 17, 2014 |
| Days to Decision | 143 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 |