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

    TACKER, MODEL R65-933

    K Number: K003949 · Decision Jul 25, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    52
    Registration Numbers
    52
    Same Product Code
    69
    Applicant Total
    23
    Review Days
    216

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    Basic Information

    Device Name
    TACKER, MODEL R65-933
    K Number
    K003949
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    A & A Medical, Inc.
    Date Received
    December 21, 2000
    Decision Date
    July 25, 2001
    Product Code
    OCW
    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
    OCW Endoscopic Tissue Approximation Device

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    Other Clearances by A & A Medical, Inc.

    K Number Device Name
    K013437 SF SH CATHETER, MODEL R65-945
    K013491 HSG CATHETER SET, 5F MODEL RGS0947, HSG CATHETER SET, 7F, MODEL R65-948
    K011512 MMODIFICATION TO LAMINARIA
    K010510 BALLOON CANNULA, SHORT, MODEL R65-985; BALLOON CANNULA, LONG, MODEL R65-985-1
    K010789 CANNULA, SURGICAL GENERAL & PLASTIC SURGERY, MODELR65-995, R65-995-1, R65-995-2, R65-997, R65-997-1
    K010056 UTERINE MANIPULATOR INJECTOR CANNULA, STERILE, MODEL R 57-450
    K000027 INSUFFLATION NEEDLE, MODEL R65-933
    K994256 SUCTION IRRIGATION TRUMPET VALVE SET, MODEL Q65-823
    K974038 THE ASPIRATOR, 6FT SILICONE TUBING, METAL TUBING ADAPTER, GLASS RESERVOIR, NEOPRENE STOPPER, ANGLED TUBE MOUNTS, FOOT
    K974138 ROCKET ELECTRODE
    Search all 23 clearances from A & A Medical, Inc. →