BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇬🇧 United Kingdom

    LiquiBand XL

    K Number: K211878 · Decision May 23, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    8
    Applicant Total
    11
    Review Days
    336

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    Basic Information

    Device Name
    LiquiBand XL
    K Number
    K211878
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4011
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Advanced Medical Solutions Limited
    Date Received
    June 21, 2021
    Decision Date
    May 23, 2022
    Product Code
    OMD
    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
    OMD Cutaneous Tissue Adhesive With Mesh

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    Other Clearances by Advanced Medical Solutions Limited

    K Number Device Name
    K223310 Antimicrobial Silicone PHMB Foam Wound Dressing
    K183570 LiquiBand Plus
    K110458 SILVER ANTIMICROBIAL WOUND GEL
    K091013 SILVER PU ANTIBACTERIAL FOAM DRESSING - NON ADHERENT AND ISLAND
    K090453 SILVER ALGINATE 11 WOUND DRESSING
    K080503 SILVER ALGINATE IV ANTIMICROBIAL WOUND DRESSING
    K081363 NON-ADHERENT ANTIMICROBIAL ALGINATE DRESSING, SILVERCEL NON-ADHERENT ANTIMICROBIAL ALGINATE DRESSING
    K073197 SILVER ANTIMICROBIAL WOUND GEL
    K070581 SILVER ALGINATE II WOUND DRESSING
    K063173 MODIFICATION TO SILVER ALGINATE II WOUND DRESSING
    Search all 11 clearances from Advanced Medical Solutions Limited →