BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    AVANCE FOAM DRESSING KIT INCL. TRANSPARENT FILM, TRANSFER PAD (SMALL, MEDIUM, LARGE) AVANCE TRANSPARENT FILM AVANCE FOAM

    K Number: K122132 · Decision Jan 17, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    105
    Registration Numbers
    105
    Same Product Code
    211
    Applicant Total
    9
    Review Days
    183

    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
    AVANCE FOAM DRESSING KIT INCL. TRANSPARENT FILM, TRANSFER PAD (SMALL, MEDIUM, LARGE) AVANCE TRANSPARENT FILM AVANCE FOAM
    K Number
    K122132
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4780
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Molnlycke Health Care
    Date Received
    July 18, 2012
    Decision Date
    January 17, 2013
    Product Code
    OMP
    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
    OMP Negative Pressure Wound Therapy Powered Suction Pump

    Similar 510(k) Clearances

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

    RENASYS EDGE (66803126)

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Nisus NPWT Canister 500-mL (CPC-500)

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Wound Geni NPWT System

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Genadyne ASTRA NPWT

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Prospera Spectruum Negative Pressure Wound Therapy Black Foam Kits and White Foam Accessory

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    extriCARE® 1000 Negative Pressure Wound Therapy System

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery
    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
    K102923 BARRIER N95 PARTICULATE RESPIRATOR
    K100029 MEPILEX BORDER AG DRESSING
    K061554 MEPILEX AG ABSORBENT SILICONE-COATED DRESSING
    K050786 BARRIER SURGICAL GOWNS
    K031131 KLINIDRAPE SURGICAL DRAPES