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

    TWIN BALLOON INJECTOR

    K Number: K902975 · Decision Sep 26, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    78
    Registration Numbers
    78
    Same Product Code
    84
    Applicant Total
    76
    Review Days
    82

    Basic Information

    Device Name
    TWIN BALLOON INJECTOR
    K Number
    K902975
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.4530
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Applicant
    ZINNANTI SURGICAL INSTRUMENTS, INC.
    Date Received
    July 6, 1990
    Decision Date
    September 26, 1990
    Product Code
    LKF
    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
    LKF Cannula, Manipulator/Injector, Uterine

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    Other Clearances by ZINNANTI SURGICAL INSTRUMENTS, INC.

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    K925560 ZSI LOOP, ZSI BALL & ZSI NEEDLE ELECTRODES
    K925960 FORCEPS FOR LAPAROSCOPIC SURGERY OB/GYN USE
    K925957 SCISSORS FOR LAPAROSCOPIC SURGERY OB/GYN USE
    K926021 NEEDLE HOLDERS & ACCESS FOR LAPAR SURG-OB/GYN USE
    K925958 SCISSOR FOR LAPAROSCOPIC SURGERY GU USE
    K926181 ZSI LAPAROSCOPES-GENERAL & PLASTIC SURGERY
    K925959 FORCEPS FOR LAPAROSCOPIC SURGERY GU USE
    Search all 76 clearances from ZINNANTI SURGICAL INSTRUMENTS, INC. →