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

    ISOLYSER SHARPS ROOM SYSTEM, MODEL 800; ISOLYSER SHARPS MANAGEMENT SYSTEM, MODELS 2400, 4000, 10000

    K Number: K090156 · Decision Sep 1, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    440
    Registration Numbers
    440
    Same Product Code
    687
    Applicant Total
    2
    Review Days
    222

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    Basic Information

    Device Name
    ISOLYSER SHARPS ROOM SYSTEM, MODEL 800; ISOLYSER SHARPS MANAGEMENT SYSTEM, MODELS 2400, 4000, 10000
    K Number
    K090156
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5570
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Wcm Waste & Compliance Management, Inc.
    Date Received
    January 22, 2009
    Decision Date
    September 1, 2009
    Product Code
    FMI
    Advisory Committee
    General Hospital
    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
    FMI Needle, Hypodermic, Single Lumen

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    Other Clearances by Wcm Waste & Compliance Management, Inc.

    K Number Device Name
    K090157 ISOLYSER HOME SHARPS MANAGEMENT (HSM), MODEL 800M; ISOLY SHARPS MANAGEMENT SYSTEM (SMS), MODELS 2400M, 4000M, 10000M, 5.