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510(k) K964441

FEMRX FOCUSED MONOPOLAR (FAP) OPERASTAR SYSTEM [OUTPATIENT ENDOSCOPIC RESECTION AND ABLATION (OPERA)] [SPECIALIZED TISSU by Gynecare Innovation Center — Product Code KNF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 28, 1997
Date Received
November 6, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Coagulator-Cutter, Endoscopic, Unipolar (And Accessories)
Device Class
Class II
Regulation Number
884.4160
Review Panel
OB
Submission Type

Other clearances by Gynecare Innovation Center

  • K980393 — SOPRANO CRYO-THERAPY SYSTEM (May 1, 1998)
  • K971305 — FEMRX FOCUSED MONOPOLAR (FMP) OPERA STAR SYSTEM (August 11, 1997)
  • K964892 — FEMRX TURP SR SYSTEM (TS27XX-YY/TS24XX-YY) (February 4, 1997)
  • K963872 — FEMRX MORCELLATOR SYSTEM (January 17, 1997)
  • K962506 — [SPECIALIZED TISSUE ASPIRATING RESECTOSCOPE (STAR)] (September 16, 1996)
  • K954775 — FLO-STAT FLUID MONITORING SYSTEM (May 10, 1996)
  • K954648 — FEMRX OPERASTAR SYSTEM (March 14, 1996)

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