Gynecare Innovation Center - FDA 510(k) Cleared Devices
8
Total
8
Cleared
0
Denied
FDA 510(k) Regulatory Record - Gynecare Innovation Center Obstetrics & Gynecology ✕
5 devices
Cleared
Aug 11, 1997
FEMRX FOCUSED MONOPOLAR (FMP) OPERA STAR SYSTEM
Obstetrics & Gynecology
125d
Cleared
Mar 28, 1997
FEMRX FOCUSED MONOPOLAR (FAP) OPERASTAR SYSTEM [OUTPATIENT ENDOSCOPIC...
Obstetrics & Gynecology
142d
Cleared
Jan 17, 1997
FEMRX MORCELLATOR SYSTEM
Obstetrics & Gynecology
113d
Cleared
May 10, 1996
FLO-STAT FLUID MONITORING SYSTEM
Obstetrics & Gynecology
206d
Cleared
Mar 14, 1996
FEMRX OPERASTAR SYSTEM
Obstetrics & Gynecology
156d