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

    FEMRX TURP SR SYSTEM (TS27XX-YY/TS24XX-YY)

    K Number: K964892 · Decision Feb 4, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    40
    Registration Numbers
    40
    Same Product Code
    23
    Applicant Total
    8
    Review Days
    60

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    Basic Information

    Device Name
    FEMRX TURP SR SYSTEM (TS27XX-YY/TS24XX-YY)
    K Number
    K964892
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Gynecare Innovation Center
    Date Received
    December 6, 1996
    Decision Date
    February 4, 1997
    Product Code
    FJL
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    FJL Resectoscope

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    Other Clearances by Gynecare Innovation Center

    K Number Device Name
    K980393 SOPRANO CRYO-THERAPY SYSTEM
    K971305 FEMRX FOCUSED MONOPOLAR (FMP) OPERA STAR SYSTEM
    K964441 FEMRX FOCUSED MONOPOLAR (FAP) OPERASTAR SYSTEM [OUTPATIENT ENDOSCOPIC RESECTION AND ABLATION (OPERA)] [SPECIALIZED TISSU
    K963872 FEMRX MORCELLATOR SYSTEM
    K962506 [SPECIALIZED TISSUE ASPIRATING RESECTOSCOPE (STAR)]
    K954775 FLO-STAT FLUID MONITORING SYSTEM
    K954648 FEMRX OPERASTAR SYSTEM