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510(k) Data Aggregation

    K Number
    K965243
    Device Name
    ENDOCARE ELECTROSURGICAL ELECTRODE
    Manufacturer
    ENDOCARE, INC.
    Date Cleared
    1997-02-25

    (64 days)

    Product Code
    GEI
    Regulation Number
    878.4400
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K954321,K944540,K945191
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The ENDOcare Electrosurgical Electrodes are designed for use in general surgery, urology, gynecology and orthopedics for cutting, coagulation, resection and vaporization of tissue including BPH (Benign Prostatic Hyperplasia), tumors, fibroids, cysts and obstructive tissue.

    Device Description

    The ENDOcare Electrosurgical Electrodes are accessories that fit commercially available resectoscopes, cystoscopes, laproscopes and hysteroscopes, pencil grips and pistol grips. Each model has a different configuration which offers the surgeon a variety of tissue interaction tips depending on the specific surgical application.

    AI/ML Overview

    This document does not contain information about acceptance criteria, device performance, study details (sample size, data provenance, expert consensus, adjudication methods), or AI/algorithm performance. It primarily describes the device (ENDOcare Electrosurgical Electrodes), its biocompatibility, substantial equivalence to previously cleared devices, and sterilization methodology. There is no mention of a study to prove acceptance criteria are met, nor any quantitative performance metrics.

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