Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K060232
    Manufacturer
    Date Cleared
    2006-07-12

    (163 days)

    Product Code
    Regulation Number
    878.4400
    Reference & Predicate Devices
    Why did this record match?
    Device Name :

    TROKAMED GMBH ELECTROSURGICAL INSTRUMENTS & ACCESSORIES

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

    The Trokemed GmbH Resectoscope & accessories are indicated for the resection of prostate tissue. The Trokamed GmbH Monopolar Electrodes are intended for use in minimal invasive techniques where unipolar electrosurgical cutting and coagulation are normally used. The Trokamed GmbH Bipolar Electrodes are intended for use in minimal invasive techniques where bipolar electrosurgical cutting and coagulation are normally used.

    The instruments are reusable; they are intended to be cleaned sterilized and reused.

    Device Description

    electrosurgical instruments and accessories

    AI/ML Overview

    I am sorry, but based on the provided text, there is no information about acceptance criteria or a study that proves a device meets those criteria. The document is a 510(k) Summary for Trokamed GmbH's electrosurgical instruments and accessories, which focuses on device description, classification, intended use, substantial equivalence to predicate devices, biocompatibility, and sterilization by the user. It also includes an FDA letter acknowledging the substantial equivalence determination and indicating the device can be marketed.

    Therefore, I cannot fulfill your request for the detailed table and information regarding acceptance criteria and studies as it is not present in the provided text.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1