BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    TOURNIQUET CUFF; PNEUMATIC TOURNIQUET

    K Number: K012632 · Decision Oct 26, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    107
    Registration Numbers
    107
    Same Product Code
    33
    Applicant Total
    5
    Review Days
    74

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    Basic Information

    Device Name
    TOURNIQUET CUFF; PNEUMATIC TOURNIQUET
    K Number
    K012632
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.5910
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Medical Instruments Technology, Inc.
    Date Received
    August 13, 2001
    Decision Date
    October 26, 2001
    Product Code
    KCY
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    KCY Tourniquet, Pneumatic

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    Other Clearances by Medical Instruments Technology, Inc.

    K Number Device Name
    K012614 KENDALL, SEQUENTIAL COMPRESSION DEVICE; HUNTLEIGH, FLOWTRON; VENAFLOW; ACUFEX; ALPS; SHEEPSKIN
    K012640 ELECTROSURGICAL CUTTING AND COAGULATION ACCESSORIES, ELECTROSURGICAL WANDS
    K012624 REPROCESSED ARTHROSCOPIC BLADES, ARTHROSCOPIC SHAVERS, SHAVER BLADE, BLADE, LIMITED REUSE BLADE, ARTHROSCOPIC BURS
    K884611 THE ORTHORANGER II ELECTRONIC GONIOMETER