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

    BIONECT CREAM

    K Number: K963004 · Decision Feb 12, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    51
    Registration Numbers
    51
    Same Product Code
    144
    Applicant Total
    10
    Review Days
    194

    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
    BIONECT CREAM
    K Number
    K963004
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent for Some Indications
    Applicant
    Fidia Pharmaceutical Corp.
    Date Received
    August 2, 1996
    Decision Date
    February 12, 1997
    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

    SILVERSITE OR CALGITROL

    FDA 510(k)
    FDA Unclassified ·Unknown

    SILVERSEAL

    FDA 510(k)
    FDA Unclassified ·Unknown

    TENDERWET ACTIVE

    FDA 510(k)
    FDA Unclassified ·Unknown
    View all

    Other Clearances by Fidia Pharmaceutical Corp.

    K Number Device Name
    K984264 MODIFICATION OF BIONECT CLEAR HYDROGEL
    K984266 MODIFICATION OF BIONECT HYDROGEL SPRAY
    K984413 BIONECT HYDROGEL
    K984262 MODIFICATION OF BIONECT HYDROGEL GAUZE PADS
    K984267 MODIFICATION OF BIONECT HYDROGEL FOAM
    K973725 BIONECT CLEAR HYDROGEL
    K973721 BIONECT HYDROGEL GAUZE PADS
    K973722 BIONECT HYDROGEL FOAM
    K973724 BIONECT HYDROGEL SPRAY