BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    FEMRX FOCUSED MONOPOLAR (FMP) OPERA STAR SYSTEM

    K Number: K971305 · Decision Aug 11, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    135
    Registration Numbers
    135
    Same Product Code
    170
    Applicant Total
    8
    Review Days
    125

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    Basic Information

    Device Name
    FEMRX FOCUSED MONOPOLAR (FMP) OPERA STAR SYSTEM
    K Number
    K971305
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.1690
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Gynecare Innovation Center
    Date Received
    April 8, 1997
    Decision Date
    August 11, 1997
    Product Code
    HIH
    Advisory Committee
    Obstetrics/Gynecology
    Review Advisory Committee
    OB
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    HIH Hysteroscope (And Accessories)

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    Other Clearances by Gynecare Innovation Center

    K Number Device Name
    K980393 SOPRANO CRYO-THERAPY SYSTEM
    K964441 FEMRX FOCUSED MONOPOLAR (FAP) OPERASTAR SYSTEM [OUTPATIENT ENDOSCOPIC RESECTION AND ABLATION (OPERA)] [SPECIALIZED TISSU
    K964892 FEMRX TURP SR SYSTEM (TS27XX-YY/TS24XX-YY)
    K963872 FEMRX MORCELLATOR SYSTEM
    K962506 [SPECIALIZED TISSUE ASPIRATING RESECTOSCOPE (STAR)]
    K954775 FLO-STAT FLUID MONITORING SYSTEM
    K954648 FEMRX OPERASTAR SYSTEM