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

    AXIOM MULTIPURPOSE WOUND DRAIN

    K Number: K993592 · Decision May 17, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    55
    Registration Numbers
    55
    Same Product Code
    74
    Applicant Total
    28
    Review Days
    208

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    Basic Information

    Device Name
    AXIOM MULTIPURPOSE WOUND DRAIN
    K Number
    K993592
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5120
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Axiom Medical, Inc.
    Date Received
    October 22, 1999
    Decision Date
    May 17, 2000
    Product Code
    BSO
    Advisory Committee
    Anesthesiology
    Review Advisory Committee
    AN
    Third Party
    N

    Classifications

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

    Product Code Device Name
    BSO Catheter, Conduction, Anesthetic

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    Other Clearances by Axiom Medical, Inc.

    K Number Device Name
    K971851 INTERPLEURAL ANESTHESIA CATHETER
    K965146 FLAT CLOSED WOUND DRAIN WITH TROCAR
    K934895 GLASSMAN SILICONE CATHETER
    K922760 ATRAUM WOUND DRESSING--MODIFICATION
    K905422 PVC ROUND WOUND DRAINS
    K904218 SUCTION SYSTEM
    K904133 DISPOSABLE FLUID COLLECTION BAG
    K863247 AXIOM TROCAR THORACIC CATHETER
    K861306 SUCTION SYSTEM
    K852614 ATRAUM WOUND DRESSING
    Search all 28 clearances from Axiom Medical, Inc. →