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

    ControlRad Sterile Cover

    K Number: K200238 · Decision Apr 26, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    200
    Registration Numbers
    200
    Same Product Code
    449
    Applicant Total
    6
    Review Days
    86

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    Basic Information

    Device Name
    ControlRad Sterile Cover
    K Number
    K200238
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4370
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Controlrad, Inc.
    Date Received
    January 31, 2020
    Decision Date
    April 26, 2020
    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 Controlrad, Inc.

    K Number Device Name
    K213455 ControlRad Select Model Z
    K211782 ControlRad Select Model Z, ControlRad Trace Model 8, ControlRad Trace Model 9
    K202431 ControlRad Select Model Z
    K200663 ControlRad Trace Model 9
    K183109 ControlRad Trace Model 8