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510(k) Data Aggregation

    K Number
    K973580
    Device Name
    INVOTEC CLEAN PAD
    Manufacturer
    INVOTEC INTERNATIONAL, INC.
    Date Cleared
    1997-12-10

    (82 days)

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

    INVOTEC CLEAN PAD

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

    THE INVOTEC CLEAN PAD may be used during any surgical procedure as an instrument wipe.

    Device Description

    Not Found

    AI/ML Overview

    The provided document is a 510(k) clearance letter from the FDA for a device called "Clean Pad." It indicates that the device has been found substantially equivalent to a predicate device and can be marketed. However, this document does not contain any information regarding acceptance criteria, performance studies, sample sizes, expert qualifications, or ground truth establishment.

    The letter is a regulatory approval document and does not detail the technical or clinical performance studies that might have been conducted to support the 510(k submission. Therefore, I cannot provide the requested information based on the given input.

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