BEUDAMED
    FDA 510(k) FDA unclassified Substantially Equivalent 🇺🇸 United States

    MEPILEX AG ABSORBENT SILICONE-COATED DRESSING

    K Number: K061554 · Decision Jan 25, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    384
    Registration Numbers
    385
    Same Product Code
    702
    Applicant Total
    9
    Review Days
    234

    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
    MEPILEX AG ABSORBENT SILICONE-COATED DRESSING
    K Number
    K061554
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Molnlycke Health Care
    Date Received
    June 5, 2006
    Decision Date
    January 25, 2007
    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

    Similar 510(k) Clearances

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

    Bonvadis®

    FDA 510(k)
    FDA Unclassified ·Unknown

    StatSeal Disc

    FDA 510(k)
    FDA Unclassified ·Unknown

    IWD-Gel™

    FDA 510(k)
    FDA Unclassified ·Unknown

    MiraChlor Antimicrobial Wound Solution

    FDA 510(k)
    FDA Unclassified ·Unknown

    Promogran Prisma™ Collagen Matrix with ORC and Silver

    FDA 510(k)
    FDA Unclassified ·Unknown

    LUOFUCON® Antimicrobial Wound Gel

    FDA 510(k)
    FDA Unclassified ·Unknown
    View all

    Other Clearances by Molnlycke Health Care

    K Number Device Name
    K130852 AVANCE® FOAM ABDOMINAL DRESSING KIT
    K130040 MEPITEL AG
    K123892 MEPILEX TRANSFER AG
    K122132 AVANCE FOAM DRESSING KIT INCL. TRANSPARENT FILM, TRANSFER PAD (SMALL, MEDIUM, LARGE) AVANCE TRANSPARENT FILM AVANCE FOAM
    K102923 BARRIER N95 PARTICULATE RESPIRATOR
    K100029 MEPILEX BORDER AG DRESSING
    K050786 BARRIER SURGICAL GOWNS
    K031131 KLINIDRAPE SURGICAL DRAPES