LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K021079
    Device Name
    ABCSNARE ELECTROSURGICAL PROBE FOR FLEXIBLE ENDOSCOPES, MODEL 1336XX
    Manufacturer
    CONMED CORP.
    Date Cleared
    2002-07-01

    (89 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 :

    ABCSNARE ELECTROSURGICAL PROBE FOR FLEXIBLE ENDOSCOPES, MODEL 1336XX

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

    These devices are intended for use with argon beam and argon plasma coagulators as flexible polypectomy snares for the cutting, resection and non-contact coagulation of polyps in the digestive tract of the human body by use of high-frequency electrosurgical energy. The argon beam provides contact-free coagulation of bleeding sites that can arise after excision of polyps and ablation of remnants of polyps. The application takes place exclusively with an endoscope.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is related to an FDA 510(k) premarket notification for an electrosurgical device (ABCSnare Electrosurgical Probe). It is a regulatory document and does not contain information about acceptance criteria or a study proving the device meets those criteria.

    Therefore, I cannot extract the requested information from the provided text. The document focuses on the FDA's determination of substantial equivalence to a predicate device, allowing the device to be marketed, rather than detailed performance study results against specific acceptance criteria.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1