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510(k) Data Aggregation

    K Number
    K112378
    Device Name
    COBES SURGICAL DRAPE
    Manufacturer
    COBES INDUSTRIES CO., LTD.
    Date Cleared
    2012-05-08

    (264 days)

    Product Code
    KKX
    Regulation Number
    878.4370
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    COBES SURGICAL DRAPE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Cobes Sterile Surgical Drape is a single use product used as a protective barrier for patient, such as to isolate a site of surgical incision from microbial and other contamination.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but based on the provided text, there is no information about the acceptance criteria or a study proving that a device meets those criteria. The document is a 510(k) premarket notification letter from the FDA regarding a sterile surgical drape, indicating that the device is substantially equivalent to legally marketed predicate devices. It discusses regulatory compliance and general information but does not contain any details about performance metrics, study designs, sample sizes, or ground truth establishment.

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