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510(k) Data Aggregation

    K Number
    K974593
    Device Name
    SEMKIN INSULATED BIPOLAR FORCEP
    Manufacturer
    TITAN MFG., INC.
    Date Cleared
    1998-06-24

    (197 days)

    Product Code
    HTD,GEI
    Regulation Number
    878.4800
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Predicate For
    K213386
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Intended to remove tissue and control bleeding by use of high frequency electrical current. (21 CFR §878.4400).

    Device Description

    Semkin Insulated Bipolar Forcep

    AI/ML Overview

    The provided document is a 510(k) clearance letter from the FDA for the Semkin Insulated Bipolar Forcep. It does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.

    The letter only states that the device is substantially equivalent to legally marketed predicate devices for its intended use, which is "Intended to remove tissue and control bleeding by use of high frequency electrical current." It also mentions general controls provisions and compliance with Good Manufacturing Practice.

    Therefore, I cannot fulfill your request for information regarding acceptance criteria and a study from this document. This typically would be found in the 510(k) summary or a more detailed technical submission, which is not provided here.

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