BEUDAMED
    FDA 510(k) FDA unclassified Substantially Equivalent 🇨🇳 China

    Antibacterial Gel Wound Dressing

    K Number: K231057 · Decision Dec 1, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    384
    Registration Numbers
    385
    Same Product Code
    702
    Applicant Total
    18
    Review Days
    232

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    Basic Information

    Device Name
    Antibacterial Gel Wound Dressing
    K Number
    K231057
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Winner Medical Co., Ltd.
    Date Received
    April 13, 2023
    Decision Date
    December 1, 2023
    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 Winner Medical Co., Ltd.

    K Number Device Name
    K252001 Collagen Wound Dressing
    K250082 Procedure mask/Surgical mask/Face mask
    K231564 Skin and Wound Cleanser
    K231152 Collagen Wound Dressing
    K221311 Antibacterial Bandage
    K223232 Procedure mask/Surgical mask/Face mask
    K221532 PHMB Wound Dressing
    K221754 Ag Foam Dressing Non-Adhesive (OTC); Ag Foam Dressing Adhesive (OTC); Silicone Ag Foam Dressing (OTC); Silicone Ag Foam Dressing with Border (OTC)
    K221755 Antimicrobial gauze sponge dressing; Antimicrobial super sponge dressing; Antimicrobial non-woven sponge dressing
    K221720 Extra Silver Gelling Fiber Dressing
    Search all 18 clearances from Winner Medical Co., Ltd. →