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

    BALLOON UTERINE STENT

    K Number: K952527 · Decision Jan 2, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    28
    Registration Numbers
    28
    Same Product Code
    57
    Applicant Total
    104
    Review Days
    215

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    Basic Information

    Device Name
    BALLOON UTERINE STENT
    K Number
    K952527
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.4530
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Cook Urological, Inc.
    Date Received
    June 1, 1995
    Decision Date
    January 2, 1996
    Product Code
    KNA
    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
    KNA Instrument, Manual, Specialized Obstetric-Gynecologic

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    Other Clearances by Cook Urological, Inc.

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    K082939 COOK FETAL MEMBRANE MANIPULATOR, MODEL -FMM-122400
    K082066 TAO BRUSH I.U.M.C. ENDOMETRIAL SAMPLER
    K082536 COOK WIRE GUIDES
    K082319 INJEKT FILIFORM INJECTION NEEDLE
    K080525 COOK ODYSSEY HOLMIUM LASER SYSTEM, MODEL 30W
    K073496 OPTILITE HOLMIUM LASER FIBERS
    K072521 COOK FIBER OPTIC BUNDLE AND FLEXOR DEFLECTING ACCESS SHEATH
    K061371 SYDNEY IVF SPERM CRYOPRESERVATION BUFFER
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