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

    Medihoney Wound Gel

    K Number: K150985 · Decision Nov 19, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    384
    Registration Numbers
    385
    Same Product Code
    702
    Applicant Total
    22
    Review Days
    219

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    Basic Information

    Device Name
    Medihoney Wound Gel
    K Number
    K150985
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Derma Sciences, Inc.
    Date Received
    April 14, 2015
    Decision Date
    November 19, 2015
    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 Derma Sciences, Inc.

    K Number Device Name
    K133279 MEDIHONEY WOUND DRESSINGS
    K110546 MEDIHONEY HYDROGEL SHEET DRESSINGS WITH ACTIVE LEPTOSPERMUM HONEY
    K101793 MEDIHONEY GEL DRESSING WITH ACTIVE MANUKA HONEY
    K081584 DERMA SCIENCES OTC MEDIHONEY DRESSINGS WITH ACTIVE MANUKA HONEY
    K080315 DERMA SCIENCES MEDIHONEY DRESSINGS WITH ACTIVE MANUKA HONEY
    K072956 MEDIHONEY PRIMARY DRESSINGS WITH ACTIVE MANUKA HONEY
    K970660 DERMAGRAN WOUND MANAGEMENT SYSTEM
    K963603 DERMAGRAN HYDROPHILIC OINTMENT
    K954739 DERMAGRAN HYDROPHILIC OINTMENT
    K954743 DERMAGRAN WOUND DRESSING CLEANER W/ZINC
    Search all 22 clearances from Derma Sciences, Inc. →