ClearanceBrief
Company ยท US

Gynecare Innovation Center

FDA 510(k) clearances and medical device recalls filed under this name, 1996 to 1998. Name variants (Inc, Corp, punctuation) are merged.

8510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)

Product codes

CodeDeviceRecords
FJLResectoscope2
HETLaparoscope, Gynecologic (And Accessories)2
HIHHysteroscope (And Accessories)2
GEIElectrosurgical, Cutting & Coagulation & Accessories1
KNFCoagulator-Cutter, Endoscopic, Unipolar (And Accessories)1

Latest 510(k) clearances

Decided510(k)Device and applicantCode
May 1, 1998K980393SOPRANO CRYO-THERAPY SYSTEM
Gynecare Innovation Center
GEI
Aug 11, 1997K971305FEMRX FOCUSED MONOPOLAR (FMP) OPERA STAR SYSTEM
Gynecare Innovation Center
HIH
Mar 28, 1997K964441FEMRX FOCUSED MONOPOLAR (FAP) OPERASTAR SYSTEM [OUTPATIENT ENDOSCOPIC RESECTION AND ABLATION (OPERA)] [SPECIALIZED TISSU
Gynecare Innovation Center
KNF
Feb 4, 1997K964892FEMRX TURP SR SYSTEM (TS27XX-YY/TS24XX-YY)
Gynecare Innovation Center
FJL
Jan 17, 1997K963872FEMRX MORCELLATOR SYSTEM
Gynecare Innovation Center
HET
Sep 16, 1996K962506[SPECIALIZED TISSUE ASPIRATING RESECTOSCOPE (STAR)]
Gynecare Innovation Center
FJL
May 10, 1996K954775FLO-STAT FLUID MONITORING SYSTEM
Gynecare Innovation Center
HET
Mar 14, 1996K954648FEMRX OPERASTAR SYSTEM
Gynecare Innovation Center
HIH

Latest recalls

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