BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    ELUTIA COATED CLOSED SURGICAL WOUND DRAIN

    K Number: K063245 · Decision Nov 28, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    0
    Applicant Total
    4
    Review Days
    398

    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
    ELUTIA COATED CLOSED SURGICAL WOUND DRAIN
    K Number
    K063245
    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
    Bacterin International, Inc.
    Date Received
    October 26, 2006
    Decision Date
    November 28, 2007
    Product Code
    OEI
    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
    OEI Drainage Catheter With Antibiotic

    Other Clearances by Bacterin International, Inc.

    K Number Device Name
    K150621 OsteoSelect PLUS Demineralized Bone Matrix Putty
    K130498 OSTEOSELECT DEMINERALIZED BONE MATRIX PUTTY
    K091321 OSTEOSELECT DEMINERALIZED BONE MATRIX PUTTY