Gynecare Innovation Center is one of 15078 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Gynecare Innovation Center - FDA 510(k) Cleared Devices
Recent clearances: SOPRANO CRYO-THERAPY SYSTEM, FEMRX FOCUSED MONOPOLAR (FMP) OPERA STAR SYSTEM, FEMRX FOCUSED MONOPOLAR (FAP) OPERASTAR SYSTEM [OUTPATIENT ENDOSCOPIC RESECTION AND ABLATION (OPERA)] [SPECIALIZED TISSU
8
Total
8
Cleared
0
Denied
Gynecare Innovation Center has 8 FDA 510(k) cleared medical devices. Based in Sunnyvale, US.
Historical record: 8 cleared submissions from 1996 to 1998. Primary specialty: Obstetrics & Gynecology.
Browse the FDA 510(k) cleared devices submitted by Gynecare Innovation Center Filter by specialty or product code using the sidebar.
FDA 510(k) Regulatory Record - Gynecare Innovation Center
8 devices
Cleared
May 01, 1998
SOPRANO CRYO-THERAPY SYSTEM
General & Plastic Surgery
88d
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
Feb 04, 1997
FEMRX TURP SR SYSTEM (TS27XX-YY/TS24XX-YY)
Gastroenterology & Urology
60d
Cleared
Jan 17, 1997
FEMRX MORCELLATOR SYSTEM
Obstetrics & Gynecology
113d
Cleared
Sep 16, 1996
[SPECIALIZED TISSUE ASPIRATING RESECTOSCOPE (STAR)]
Gastroenterology & Urology
81d
Cleared
May 10, 1996
FLO-STAT FLUID MONITORING SYSTEM
Obstetrics & Gynecology
206d
Cleared
Mar 14, 1996
FEMRX OPERASTAR SYSTEM
Obstetrics & Gynecology
156d