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510(k) Data Aggregation

    K Number
    K955756
    Device Name
    KARL STORZ POINT COAGULATOR, SEMM CROCODILE FORCEPS, MYOMA ENUCLEATOR
    Manufacturer
    KARL STORZ ENDOSCOPY-AMERICA, INC.
    Date Cleared
    1996-11-26

    (343 days)

    Product Code
    HGI
    Regulation Number
    884.4120
    Type
    Traditional
    Panel
    Obstetrics/Gynecology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The KSEA thermocoagulation accessories are designed to thermally coagulate tissue during laparoscopic surgical procedures in gynecology.

    Device Description

    The KSEA thermocoagulator accessories are manually operated, reusable surgical devices consisting of a point coagulator, crocodile forceps and a myoma enucleator. The instruments are long enough to gain access to the surgical area and are designed to be used as accessories to laparoscopes. The body contact materials are surgical grade stainless steel.

    AI/ML Overview

    The provided document is a 510(k) Summary of Safety and Effectiveness for Karl Storz Endoscopy-America, Inc.'s Laparoscopic Thermocoagulator accessories, dated November 26, 1999.

    This document does not contain information regarding acceptance criteria, device performance results from a study, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details.

    The summary focuses on describing the device, its intended use, and establishing substantial equivalence to predicate devices based on design and intended use, rather than presenting a performance study with specific criteria and results. Therefore, I cannot complete the requested information based on the provided text.

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