BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    SCARAID SILICONE GEL SHEETING

    K Number: K992146 · Decision Jul 30, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    190
    Registration Numbers
    190
    Same Product Code
    80
    Applicant Total
    5
    Review Days
    36

    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
    SCARAID SILICONE GEL SHEETING
    K Number
    K992146
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4025
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Biodermis Corp.
    Date Received
    June 24, 1999
    Decision Date
    July 30, 1999
    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 Biodermis Corp.

    K Number Device Name
    K003948 EPI-DERM SILICONE GEL SHEETING
    K991604 EPI-FOAM SILICONE SHEETING
    K964047 CRYOSIL SILICONE GEL SHEETING
    K942156 EPI-DERM SILICONE GEL SHEETING