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

    FINGER TOURNIQUETTE

    K Number: K853472 · Decision Oct 10, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    335
    Registration Numbers
    335
    Same Product Code
    19
    Applicant Total
    1
    Review Days
    51

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    FINGER TOURNIQUETTE
    K Number
    K853472
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.5900
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Joseph B. Marogil
    Date Received
    August 20, 1985
    Decision Date
    October 10, 1985
    Product Code
    GAX
    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
    GAX Tourniquet, Nonpneumatic

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (GAX), ordered by most recent decision date.

    UNIQUET

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    TOURNIQUET

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    STERILE ESMARCH BANDAGE

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    DEGANIA SILICONE TOURNIQUET

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    UNIVERSAL TOURNIQUET

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    KINDERWRAP

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery
    View all