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510(k) Data Aggregation

    K Number
    K981819
    Device Name
    ANGIOLAZ VES-1CAM
    Manufacturer
    ANGIOLAZ, INC.
    Date Cleared
    1998-08-04

    (74 days)

    Product Code
    FWF
    Regulation Number
    878.4160
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    ANGIOLAZ VES-1CAM

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

    The VES-1CAM use is indicated when ever there is a need for the use of video in endoscopic procedure.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for the Angiolaz VES-1Cam device, dated August 4, 1998. It primarily confirms the device's substantial equivalence to a legally marketed predicate device and grants permission to market it.

    Based on the provided text, there is no information available regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.

    The letter focuses on regulatory approval and states the device's intended use: "The VES-1CAM use is indicated whenever there is a need for the use of video in endoscopic procedure."

    Therefore, I cannot fulfill your request for the specific details about acceptance criteria and the study that proves the device meets them from the provided text. This information would typically be found in the 510(k) submission itself, not in the clearance letter.

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