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510(k) Data Aggregation

    K Number
    K960805
    Device Name
    ARTHOSCOPE
    Manufacturer
    UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC
    Date Cleared
    1996-04-10

    (42 days)

    Product Code
    HRX
    Regulation Number
    888.1100
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K933576
    Why did this record match?
    Reference Devices :

    K933576

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

    Both the Auto Suture* Arthroscope** and the Auto Suture* Disposable Arthroscope** (K933576) are intended to be used in orthopedic surgery for the arthroscopic illumination and viewing of joint capsules.

    Device Description

    The Auto Suture* Arthroscope** is a reusable arthroscope which has a 30° field of view and a diameter maximum of 4.75 mm. The device utilizes a fiber optic light transmission system to illuminate the joint capsule and an optical system to view the capsule.

    AI/ML Overview

    The provided text describes a 510(k) submission for an arthroscope, focusing on its description, predicate device, and intended use. It does not contain any information regarding acceptance criteria, device performance metrics, study design, sample sizes, expert involvement, or any form of AI or algorithm performance assessment.

    Therefore, I cannot fulfill your request for the detailed description of acceptance criteria and the study that proves the device meets them based on the provided input.

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