LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K073452
    Device Name
    MODIFICATION TO: ARAGON SURGICAL LAPCAP
    Manufacturer
    ARAGON SURGICAL INC.
    Date Cleared
    2008-01-11

    (32 days)

    Product Code
    HIF
    Regulation Number
    884.1730
    Type
    Special
    Panel
    Obstetrics/Gynecology
    Reference & Predicate Devices
    K070651
    Why did this record match?
    Device Name :

    MODIFICATION TO: ARAGON SURGICAL LAPCAP

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

    The Aragon Surgical LapCap is intended for use in the peri-umbilical region of the abdominal wall with a Veress needle for the establishment of a pneumoperitoneum during gynecologic (pelvic) and general surgical (intraabdominal) laparoscopic procedures.

    Device Description

    The Aragon Surgical LapCap is a single-use device used during laparoscopic surgical procedures. The device consists of a bell-shaped polycarbonate dome housing containing a pass-through port for introduction of a standard Veress needle and a vacuum port for attachment to a standard hospital vacuum line.

    AI/ML Overview

    The provided text does not contain any information about acceptance criteria or a study proving device performance.

    The document is a 510(k) summary and the FDA's clearance letter for the Aragon Surgical LapCap. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed performance studies or pre-defined acceptance criteria for the new device's efficacy or accuracy.

    Therefore, I cannot populate the requested table and information points as the source material does not contain the necessary details.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1