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510(k) K954648

FEMRX OPERASTAR SYSTEM by Gynecare Innovation Center — Product Code HIH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 14, 1996
Date Received
October 10, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Hysteroscope (And Accessories)
Device Class
Class II
Regulation Number
884.1690
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)
  • K964441 — FEMRX FOCUSED MONOPOLAR (FAP) OPERASTAR SYSTEM [OUTPATIENT ENDOSCOPIC RESECTION (March 28, 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)

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