FDA 510(k) Applications Submitted by GYNECARE INNOVATION CENTER

FDA 510(k) Number Submission Date Device Name Applicant
K971305 04/08/1997 FEMRX FOCUSED MONOPOLAR (FMP) OPERA STAR SYSTEM GYNECARE INNOVATION CENTER
K980393 02/02/1998 SOPRANO CRYO-THERAPY SYSTEM GYNECARE INNOVATION CENTER
K964892 12/06/1996 FEMRX TURP SR SYSTEM (TS27XX-YY/TS24XX-YY) GYNECARE INNOVATION CENTER
K962506 06/27/1996 [SPECIALIZED TISSUE ASPIRATING RESECTOSCOPE (STAR)] GYNECARE INNOVATION CENTER
K963872 09/26/1996 FEMRX MORCELLATOR SYSTEM GYNECARE INNOVATION CENTER
K954648 10/10/1995 FEMRX OPERASTAR SYSTEM GYNECARE INNOVATION CENTER
K954775 10/17/1995 FLO-STAT FLUID MONITORING SYSTEM GYNECARE INNOVATION CENTER
K964441 11/06/1996 FEMRX FOCUSED MONOPOLAR (FAP) OPERASTAR SYSTEM [OUTPATIENT ENDOSCOPIC RESECTION AND ABLATION (OPERA)] [SPECIALIZED TISSU GYNECARE INNOVATION CENTER


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