Company ยท US
Gynex Corp.
FDA 510(k) clearances and medical device recalls filed under this name, 1998 to 2006. Name variants (Inc, Corp, punctuation) are merged.
5510(k) clearances (0 in 12 months)
1recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 7, 2006 | K061306 | CO-1000 COLPOSCOPE, MULTIPLE Gynex Corp. | HEX |
| Mar 12, 1999 | K982739 | GYNEX ELECTRODES Gynex Corp. | HGI |
| Aug 21, 1998 | K980238 | GYNEX EXTENDED REACH NEEDLE Gynex Corp. | HEE |
| Apr 8, 1998 | K980237 | GYNEX ENDOSPECULUM Gynex Corp. | KNA |
| Mar 17, 1998 | K980247 | GYNEX IRIS HOOK, GYNEX ANGLE HOOK, GYNEX EMMETT TENACULUM Gynex Corp. | HDC |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 3, 2012 | Gynex Corporation Sterile, single-use, disposable electrosurgical electrode holder. It connects the electrode to the foot activated electric generator. Label reads in part "***GYNEX*** Electrode Handpiece, Foot Activ Terminated |
HGI | None listed |