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

    RENASYS WOUND+ Dressing Kit with AIRLOCK Technology

    K Number: K251826 · Decision Sep 11, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    105
    Registration Numbers
    105
    Same Product Code
    211
    Applicant Total
    8
    Review Days
    90

    Basic Information

    Device Name
    RENASYS WOUND+ Dressing Kit with AIRLOCK Technology
    K Number
    K251826
    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
    Smith & Nephew Medical, Ltd.
    Date Received
    June 13, 2025
    Decision Date
    September 11, 2025
    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 Smith & Nephew Medical, Ltd.

    K Number Device Name
    K260646 RENASYS EDGE (66803126)
    K243576 RENASYS Foam Wound Dressing Kit with AIRLOCK Technology and Soft Port; RENASYS Gauze Wound Dressing Kit with AIRLOCK Technology and Soft Port
    K231939 Renasys Edge
    K190730 IODOSORB
    K190756 IODOFLEX
    K153209 RENASYS TOUCH Negative Pressure Wound Therapy, RENASYS TOUCH Canisters, RENASYS TOUCH Carry Bag, Carry Strap, RENASYS Y-Connector, RENASYS TOUCH IV Pole/Bed Clamp, RENASYS TOUCH Class 2 Power Supply
    K151436 PICO Single Use Negative Pressure Wound Therapy System