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510(k) Data Aggregation

    K Number
    K970642

    Validate with FDA (Live)

    Device Name
    TENOSCOPE
    Manufacturer
    LUXTEC CORP.
    Date Cleared
    1997-05-21

    (90 days)

    Product Code
    HRX
    Regulation Number
    888.1100
    Type
    Traditional
    Panel
    Orthopedic
    Age Range
    All
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The TenoScope is indicated for the visualization and diagnosis of a severed tendon which has retracted within its diagnosis of a severed conacial by non-invasive maneuvers.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a device called "TenoScope". It does not contain information about acceptance criteria, device performance, test studies, sample sizes, or expert qualifications. It is purely regulatory correspondence confirming that the device is substantially equivalent to a predicate device and can be marketed.

    Therefore, I cannot fulfill your request for information regarding acceptance criteria and study details based on the provided text.

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