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510(k) K963872

FEMRX MORCELLATOR SYSTEM by Gynecare Innovation Center — Product Code HET

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 17, 1997
Date Received
September 26, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Laparoscope, Gynecologic (And Accessories)
Device Class
Class II
Regulation Number
884.1720
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)
  • 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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