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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Coagulator-Cutter, Endoscopic, Unipolar (And Accessories)
510(k) Number K964441
Device Name FEMRX FOCUSED MONOPOLAR (FAP) OPERASTAR SYSTEM [OUTPATIENT ENDOSCOPIC RESECTION AND ABLATION (OPERA)] [SPECIALIZED TISSU
Applicant
GYNECARE INNOVATION CENTER
1221 INNSBRUCK DR.
SUNNYVALE,  CA  94089
Applicant Contact MICHAEL A DANIEL
Correspondent
GYNECARE INNOVATION CENTER
1221 INNSBRUCK DR.
SUNNYVALE,  CA  94089
Correspondent Contact MICHAEL A DANIEL
Regulation Number884.4160
Classification Product Code
KNF  
Subsequent Product Code
HIH  
Date Received11/06/1996
Decision Date 03/28/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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