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510(k) Data Aggregation

    K Number
    K072126
    Device Name
    HABIB VESEAL
    Manufacturer
    EMCISION, LTD.
    Date Cleared
    2007-10-02

    (61 days)

    Product Code
    GEI
    Regulation Number
    878.4400
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K974521
    Why did this record match?
    Device Name :

    HABIB VESEAL

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

    The Habib™ VesCoag is a catheter intended to be used for the coagulation of blood vessels during general surgery.

    Device Description

    The Habib™ VesCoag is a bipolar radiofrequency (RF) device that consists of a catheter, wire connections, hub, Y connector and two ring electrodes are configured with two rings creating proximal and distal heating zones. The Habib™ VesCoag has an attached cable which connects the device to an RF Generator. The catheter is inserted into the vessel and the tissue is coagulated using the RF power. The Habib™ VesCoag is designed for use in surgery and in imaging/radiological procedures and is a single use sterile device.

    AI/ML Overview

    The provided text is a Fragment of a 510(k) summary for the Habib™ VesCoag. This type of regulatory document typically focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed independent study with specific acceptance criteria and performance metrics.

    Based solely on the provided text, here's what can be extracted and what cannot:

    1. A table of acceptance criteria and the reported device performance

    The provided document does not explicitly state predefined acceptance criteria for specific performance metrics of the Habib™ VesCoag in a quantifiable way (e.g., "coagulation time

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