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

    SILVERSITE OR CALGITROL

    K Number: K041268 · Decision Sep 20, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    51
    Registration Numbers
    51
    Same Product Code
    144
    Applicant Total
    6
    Review Days
    131

    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
    SILVERSITE OR CALGITROL
    K Number
    K041268
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Adri
    Date Received
    May 12, 2004
    Decision Date
    September 20, 2004
    Product Code
    MGQ
    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
    MGQ Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic

    Similar 510(k) Clearances

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

    HylaGuard Moisturizing Cream

    FDA 510(k)
    FDA Unclassified ·Unknown

    HYLATOPIC EMOLLIENT FOAM

    FDA 510(k)
    FDA Unclassified ·Unknown

    IMPRUV A.I. CREAM WOUND AND SKIN EMULSION

    FDA 510(k)
    FDA Unclassified ·Unknown

    SILVERSEAL

    FDA 510(k)
    FDA Unclassified ·Unknown

    TENDERWET ACTIVE

    FDA 510(k)
    FDA Unclassified ·Unknown

    MEDTRADE PRODUCT'S ANTISEPTIC BARRIER HYDROGEL DRESSINGS

    FDA 510(k)
    FDA Unclassified ·Unknown
    View all

    Other Clearances by Adri

    K Number Device Name
    K011618 CALGITROL AG SILVER ALGINATE WOUND DRESSING
    K000054 FOAM CALCIUM ALGINATE TOPICAL WOUND DRESSING WITH COLLAGEN
    K963656 FOAM CALCIUM ALIGINATE TOPICAL WOUND DRESSING
    K940404 ALGINATE FIBER TOPICAL WOUND DRESSING
    K870383 ALGINATE WOOL FIBER