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510(k) Data Aggregation

    K Number
    K982746
    Device Name
    MONOPOLAR SUCTION COAGULATOR, MODEL # SB 110-1
    Manufacturer
    NEW DEANTRONICS TAIWAN, LTD.
    Date Cleared
    1998-09-14

    (39 days)

    Product Code
    GEI
    Regulation Number
    878.4400
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    MONOPOLAR SUCTION COAGULATOR, MODEL # SB 110-1

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

    Electrosurgical accessory. Monopolar electrosurgical coagulator for controlling bleeding by use of high-frequency electrical current and a suction tube for removal of fluids and debris from the surgical site.

    Device Description

    Monopolar Suction Coagulator

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a Monopolar Suction Coagulator. It does not contain any information regarding acceptance criteria or a study that proves the device meets specific performance criteria related to AI or algorithm performance.

    The letter is a regulatory document confirming that the device is substantially equivalent to legally marketed predicate devices and can be marketed. It focuses on regulatory compliance, classification, and general controls, not on detailed performance metrics from a specific study.

    Therefore, I cannot extract the requested information from the provided text.

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