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

    D2 Dressing

    K Number: DEN160012 · Decision Jun 30, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    15
    Registration Numbers
    15
    Same Product Code
    5
    Applicant Total
    6
    Review Days
    471

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    Basic Information

    Device Name
    D2 Dressing
    K Number
    DEN160012
    Device Class
    FDA class 2
    Clearance Type
    Direct
    Regulation Number
    878.4454
    Medical Specialty
    General, Plastic Surgery
    Decision
    Unknown
    Applicant
    Z-Medica, LLC
    Date Received
    March 16, 2016
    Decision Date
    June 30, 2017
    Product Code
    POD
    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
    POD Temporary, Internal Use Hemostatic

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    Other Clearances by Z-Medica, LLC

    K Number Device Name
    K220971 QuikClot Control+ Hemostatic Dressing
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    K181641 QuikClot Radial
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    K123387 QUIKCLOT HEMOSTATIC DRESSING