BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    SURGIDYNE SURGIFLO C.W.S. DRAIN PRODUCTS

    K Number: K850634 · Decision Jun 28, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    213
    Registration Numbers
    213
    Same Product Code
    95
    Applicant Total
    6
    Review Days
    129

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    Basic Information

    Device Name
    SURGIDYNE SURGIFLO C.W.S. DRAIN PRODUCTS
    K Number
    K850634
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4680
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Surgidyne, Inc.
    Date Received
    February 19, 1985
    Decision Date
    June 28, 1985
    Product Code
    GCY
    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
    GCY Apparatus, Suction, Single Patient Use, Portable, Nonpowered

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    Other Clearances by Surgidyne, Inc.

    K Number Device Name
    K892334 LEONARD TUBE
    K883582 VARIDYNE MODEL 250 SUCTION DRAINAGE SYSTEM
    K864822 VARIDYNE 550, MODELS 12E,12M,24E & 24M SUCTION SYS
    K860030 SURGIDYNE VARIDYNE, MODEL 140-2I & MODEL 140-2ID
    K852180 SURGIDYNES VARIDYNE 350-2I & 350-2C CORDLESS ELEC.