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

    DAVIS+GECK VALTRAC BIOFRAG ANASTOMOSIS RING

    K Number: K931056 · Decision Jul 8, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    136
    Registration Numbers
    136
    Same Product Code
    282
    Applicant Total
    7
    Review Days
    129

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    Basic Information

    Device Name
    DAVIS+GECK VALTRAC BIOFRAG ANASTOMOSIS RING
    K Number
    K931056
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4750
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    American Cyanamid Co.
    Date Received
    March 1, 1993
    Decision Date
    July 8, 1993
    Product Code
    GDW
    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
    GDW Staple, Implantable

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    Other Clearances by American Cyanamid Co.

    K Number Device Name
    K930992 FLEXON AND STAINLESS STEEL SUTURES
    K921696 CUTTING AND COAGULATION DEVICES AND ACCESSORIES
    K922348 VALTRAC(R) INTRODUCER FORCEP
    K900198 DEXON II ABSORBABLE SURGICAL SUTURE, U.S.P.
    K896946 COATED NOVAFIL, POLYBUTESTER, MESH
    K823552 APPOSE SKIN STAPLER & REMOVER