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510(k) Data Aggregation

    K Number
    K990602
    Date Cleared
    1999-07-01

    (127 days)

    Product Code
    Regulation Number
    878.5040
    Reference & Predicate Devices
    Why did this record match?
    Device Name :

    RICHTER LIPOPLASTY CANNULAS AND ACCESSORIES

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

    The Richter Lipoplasty Cannulas and Accessories are intended for use in aesthetic body contouring.

    Device Description

    The Richter Livoplasty Cannulas consist of a hollow stainless steel tube, with various tip shapes, lengths and diameters. The cannulas are provided with an attached aluminum handle for aspirator connection or with aluminum couplings for syringe connection. The cannulas are available with an optional PTFE coating. The Richter Lipoplasty cannulas are provided nonsterile

    AI/ML Overview

    The provided text from the FDA 510(k) notification for "Richter Lipoplasty Cannulas And Accessories" does not contain information about acceptance criteria or a study proving the device meets those criteria.

    This document is a letter from the FDA stating that the device is substantially equivalent to previously marketed devices, allowing it to proceed to market. It describes the device, identifies predicate devices, and confirms its intended use and classification. However, it does not include details about device performance metrics, clinical study design, sample sizes, expert qualifications, or ground truth establishment.

    Therefore, I cannot provide a table of acceptance criteria and reported device performance or information about a study based on the provided text.

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