K120743 is an FDA 510(k) clearance for the SPECULUM, VAGINAL, NONMETAL. This device is classified as a Speculum, Vaginal, Nonmetal (Class II - Special Controls, product code HIB).
Submitted by Welch Allyn, Inc. (Skaneateles Falls, US). The FDA issued a Cleared decision on March 23, 2012, 11 days after receiving the submission on March 12, 2012.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.4530.
| 510(k) Number | K120743 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 12, 2012 |
| Decision Date | March 23, 2012 |
| Days to Decision | 11 days |
| Submission Type | Special |
| 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 |