K980247 is an FDA 510(k) clearance for the GYNEX IRIS HOOK, GYNEX ANGLE HOOK, GYNEX EMMETT TENACULUM. This device is classified as a Tenaculum, Uterine (Class II - Special Controls, product code HDC).
Submitted by Gynex Corp. (Concord, US). The FDA issued a Cleared decision on March 17, 1998, 53 days after receiving the submission on January 23, 1998.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.4530.
| 510(k) Number | K980247 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 23, 1998 |
| Decision Date | March 17, 1998 |
| Days to Decision | 53 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 |