BEUDAMED
    FDA 510(k) FDA unclassified Substantially Equivalent 🇬🇧 United Kingdom

    High Performance Antimicrobial Gelling Fiber with Silver

    K Number: K210974 · Decision May 12, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    384
    Registration Numbers
    385
    Same Product Code
    702
    Applicant Total
    11
    Review Days
    41

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    Basic Information

    Device Name
    High Performance Antimicrobial Gelling Fiber with Silver
    K Number
    K210974
    Device Class
    FDA unclassified
    Clearance Type
    Special
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Advanced Medical Solutions, Ltd.
    Date Received
    April 1, 2021
    Decision Date
    May 12, 2021
    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 Advanced Medical Solutions, Ltd.

    K Number Device Name
    K213473 Antimicrobial Gelling Fiber Dressing with PHMB
    K190819 Silicone PHMB Foam Wound Dressing
    K183645 Silver High Performance Dressing
    K180634 Surgical Silver Post Operative Dressing
    K181197 PHMB Foam Wound Dressing
    K163062 PHMB Antimicrobial Foam Wound Dressing
    K032742 SILVER FOAM WOUND DRESSING
    K041316 ANTIMICROBIAL ALGINATE DRESSING
    K024298 ANTIMICROBIAL ALGINATE DRESSING
    K010245 ACTIVHEAL SCAR MANAGEMENT DRESSING
    Search all 11 clearances from Advanced Medical Solutions, Ltd. →