BEUDAMED
    FDA 510(k) FDA unclassified Substantially Equivalent 🇨🇦 Canada

    KerraCel Ag Gelling Fiber Silver Dressing

    K Number: K162508 · Decision Feb 13, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    384
    Registration Numbers
    385
    Same Product Code
    702
    Applicant Total
    7
    Review Days
    158

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    Basic Information

    Device Name
    KerraCel Ag Gelling Fiber Silver Dressing
    K Number
    K162508
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Exciton Technologies, Inc.
    Date Received
    September 8, 2016
    Decision Date
    February 13, 2017
    Product Code
    FRO
    Advisory Committee
    Unknown
    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
    FRO Dressing, Wound, Drug

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    Other Clearances by Exciton Technologies, Inc.

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    K113564 EXSALT T7 WOUND DRESSING
    K103067 EXSALT SD7 WOUND DRESSING
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