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Gynecare Innovation Center

FDA 510(k) & PMA Approved Devices — 8 products

Total Devices8

Categories0

Latest FDA decision

Type	Number	Device Name	Code	Date	Actions
510(k)	K980393	SOPRANO CRYO-THERAPY SYSTEM	GEI	1998-05-01	View
510(k)	K971305	FEMRX FOCUSED MONOPOLAR (FMP) OPERA STAR SYSTEM	HIH	1997-08-11	View
510(k)	K964441	FEMRX FOCUSED MONOPOLAR (FAP) OPERASTAR SYSTEM [OUTPATIENT ENDOSCOPIC RESECTION AND ABLATION (OPERA)] [SPECIALIZED TISSU	KNF	1997-03-28	View
510(k)	K964892	FEMRX TURP SR SYSTEM (TS27XX-YY/TS24XX-YY)	FJL	1997-02-04	View
510(k)	K963872	FEMRX MORCELLATOR SYSTEM	HET	1997-01-17	View
510(k)	K962506	[SPECIALIZED TISSUE ASPIRATING RESECTOSCOPE (STAR)]	FJL	1996-09-16	View
510(k)	K954775	FLO-STAT FLUID MONITORING SYSTEM	HET	1996-05-10	View
510(k)	K954648	FEMRX OPERASTAR SYSTEM	HIH	1996-03-14	View

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