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

    BIONECT HYDROGEL FOAM

    K Number: K973722 · Decision Sep 22, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    51
    Registration Numbers
    51
    Same Product Code
    144
    Applicant Total
    10
    Review Days
    357

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    Basic Information

    Device Name
    BIONECT HYDROGEL FOAM
    K Number
    K973722
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Fidia Pharmaceutical Corp.
    Date Received
    September 30, 1997
    Decision Date
    September 22, 1998
    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

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    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
    K973724 BIONECT HYDROGEL SPRAY
    K963004 BIONECT CREAM