BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇬🇧 United Kingdom

    ACTIVHEAL SCAR MANAGEMENT DRESSING

    K Number: K010245 · Decision Apr 25, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    190
    Registration Numbers
    190
    Same Product Code
    80
    Applicant Total
    11
    Review Days
    90

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    ACTIVHEAL SCAR MANAGEMENT DRESSING
    K Number
    K010245
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4025
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Advanced Medical Solutions, Ltd.
    Date Received
    January 25, 2001
    Decision Date
    April 25, 2001
    Product Code
    MDA
    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
    MDA Elastomer, Silicone, For Scar Management

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (MDA), ordered by most recent decision date.

    NEODYNE DRESSING

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    CORELEADER SCAR-DIMMER

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    BEAU RX SCAR CARE GEL

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    KELO-COTE SPRAY

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    NEWGEL AND NEWGEL PLUS E

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    HANSON SCAR ADE

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery
    View all

    Other Clearances by Advanced Medical Solutions, Ltd.

    K Number Device Name
    K213473 Antimicrobial Gelling Fiber Dressing with PHMB
    K210974 High Performance Antimicrobial Gelling Fiber with Silver
    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
    Search all 11 clearances from Advanced Medical Solutions, Ltd. →