LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K994087
    Device Name
    SUPERSTITCH
    Manufacturer
    SUTURA, INC.
    Date Cleared
    2000-03-01

    (89 days)

    Product Code
    OCW,GAW,GCJ
    Regulation Number
    876.1500
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    K934738,K925149,K963965
    Why did this record match?
    Reference Devices :

    K934738, K925149

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

    SuperStitch® is indicated for use in performing vascular stitching in general surgery, including endoscopic procedures. It is not intended for blind vascular closure.

    Device Description

    The SuperStitch® device is designed for use with or without an access device (e.g., trocar, sheath, or cannula) depending on the endoscopic technique, for use during minimally invasive surgical procedures, or for application directly to a vessel or wound site in an open setting. SuperStitch® applies one nonabsorbable sterile surgical suture. The knot pusher is comprised of two components: a snare to capture one strand of the The safet positive is veniprises or used to advance the tied knot to the surface of the tissue.

    AI/ML Overview

    I am sorry, but the provided text does not contain any information about acceptance criteria or a study that proves a device meets such criteria. The document is a 510(k) premarket notification letter from the FDA regarding the "SuperStitch® Vascular Suturing Device", and it primarily discusses regulatory classification, indications for use, and a summary of safety and effectiveness related to establishing substantial equivalence to predicate devices.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them, as this information is not present in the given text.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1