K073182 is an FDA 510(k) clearance for the GYN DISPOSABLES TENACULUM 356T, a Tenaculum, Uterine (Class II — Special Controls, product code HDC), submitted by Gyn-Disposables, Inc. (Memphis, US). The FDA issued a Cleared decision on November 28, 2007, 15 days after receiving the submission on November 13, 2007. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.4530.
| 510(k) Number | K073182 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | November 13, 2007 |
| Decision Date | November 28, 2007 |
| Days to Decision | 15 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | HDC — Tenaculum, Uterine |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 884.4530 |