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

    MODIFICATION TO: COMPEL SURGICAL DRAPES

    K Number: K012807 · Decision Oct 11, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    200
    Registration Numbers
    200
    Same Product Code
    449
    Applicant Total
    23
    Review Days
    50

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    Basic Information

    Device Name
    MODIFICATION TO: COMPEL SURGICAL DRAPES
    K Number
    K012807
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    878.4370
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Standard Textile Co., Inc.
    Date Received
    August 22, 2001
    Decision Date
    October 11, 2001
    Product Code
    KKX
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    KKX Drape, Surgical, Antimicrobial

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    Other Clearances by Standard Textile Co., Inc.

    K Number Device Name
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    K060181 COMPE1 1 -PLY SURGICAL GOWNS
    K041653 COMPEL 1-PLY SURGICAL GOWNS; COMPEL ISOLATION GOWNS
    K041540 COMBOSAFE (EUROPE) AND PROMAX (US) SURGICAL GOWNS
    K041539 COMPEL SURGICAL GOWNS
    K041541 COMPEL MLR SURGICAL GOWNS
    K012268 TRIMAX
    K010799 COMBOSAFE SURGICAL GOWNS, NON-STERILE (75X REUSABLE)
    Search all 23 clearances from Standard Textile Co., Inc. →