K910287 is an FDA 510(k) clearance for the OTT CERVICAL TENACULUM. This device is classified as a Tenaculum, Uterine (Class II - Special Controls, product code HDC).
Submitted by Marlo Surgical Technology (Willoughby, US). The FDA issued a Cleared decision on February 28, 1991, 37 days after receiving the submission on January 22, 1991.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.4530.
| 510(k) Number | K910287 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 22, 1991 |
| Decision Date | February 28, 1991 |
| Days to Decision | 37 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | — |
| Product Code | HDC — Tenaculum, Uterine |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.4530 |