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

    SALUTE FIXATION SYSTEM

    K Number: K050610 · Decision May 25, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    136
    Registration Numbers
    136
    Same Product Code
    282
    Applicant Total
    24
    Review Days
    76

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    Basic Information

    Device Name
    SALUTE FIXATION SYSTEM
    K Number
    K050610
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4750
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Davol Inc., Sub. C. R. Bard, Inc.
    Date Received
    March 10, 2005
    Decision Date
    May 25, 2005
    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 Davol Inc., Sub. C. R. Bard, Inc.

    K Number Device Name
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    K081010 BARD 3DMAX MESH
    K061754 BARD COMPOSITE L/P MESH
    K061314 BARD EXTRA LARGE COMPOSIX KUGEL HERNIA PATCH
    K051848 SALUTE II DISPOSABLE FIXATION DEVICE, MODELS 0113070, 0113072, 0113073, 0113077, 0113079
    K011069 AQUASENS FLUID MONITORING SYSTEM
    K003674 NEZHAT-DORSEY REUSABLE ELECTROSURGICAL ATTACHMENTS: J-HOOK TIP, L-HOOK TIP, CORBITT SPATULA TIP, NEEDLE TIP, BALL TIP
    K991799 DAVOL HYSTEROSCOPY POUCH DRAPE AND TUBING SET, MODEL OOXXXXO
    K991637 BARD SPERMA-TEX PRESHAPED MESH (2.4X5.6), MODEL 0114700
    Search all 24 clearances from Davol Inc., Sub. C. R. Bard, Inc. →