LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K960791
    Device Name
    KARL STORZ HUZLY HIGH-FREQUENCY CUTTING LOOPS
    Manufacturer
    KARL STORZ ENDOSCOPY-AMERICA, INC.
    Date Cleared
    1996-03-11

    (13 days)

    Product Code
    EOQ
    Regulation Number
    874.4680
    Type
    Traditional
    Panel
    Ear Nose & Throat
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The KSEA Huzly high-frequency cutting loops are designed to remove various pathologies of the bronchi and/or esophagus using high-frequency electrical current during ENT endoscopic surgical procedures.

    Device Description

    The KSEA Huzly high-frequency cutting loops are manually operated, reusable surgical devices consisting of a bronchoscope tube with a cutting loop and connection for a highfrequency cord. The Huzly high-frequency cutting loops are available in both adult and pediatric sizes, which are long enough to gain access to the surgical area. The body contact materials are surgical grade stainless steel and tungsten.

    AI/ML Overview

    This document is a 510(k) summary for a medical device (KSEA Huzly high-frequency cutting loops) and does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria.

    The 510(k) summary focuses on demonstrating substantial equivalence to predicate devices, device description, and intended use, rather than presenting a performance study with specific acceptance criteria.

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

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1