Medical Device Manufacturer · US , Redmond , WA

Gynex Corp. - FDA 510(k) Cleared Devices

5 submissions · 5 cleared · Since 1998

Recent clearances: CO-1000 COLPOSCOPE, MULTIPLE, GYNEX ELECTRODES, GYNEX EXTENDED REACH NEEDLE

View 5 510(k) Devices ↓

5

Total

5

Cleared

0

Denied

FDA 510(k) Regulatory Record - Gynex Corp. Obstetrics & Gynecology ✕

5 devices

1-5 of 5

Cleared Aug 07, 2006

CO-1000 COLPOSCOPE, MULTIPLE

Obstetrics & Gynecology · 89d

Cleared Mar 12, 1999

GYNEX ELECTRODES

Obstetrics & Gynecology · 218d

Cleared Aug 21, 1998

GYNEX EXTENDED REACH NEEDLE

Obstetrics & Gynecology · 210d

Cleared Apr 08, 1998

GYNEX ENDOSPECULUM

Obstetrics & Gynecology · 75d

Cleared Mar 17, 1998

GYNEX IRIS HOOK, GYNEX ANGLE HOOK, GYNEX EMMETT TENACULUM

Obstetrics & Gynecology · 53d