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510(k) Data Aggregation

    K Number
    K970873
    Device Name
    ENDOSOFT SOFT TIP NEEDLE (20 GA. AND 19 GA.)
    Manufacturer
    AMERICAN MEDICAL DEVICES, INC.
    Date Cleared
    1997-05-20

    (71 days)

    Product Code
    HMX
    Regulation Number
    886.4350
    Type
    Traditional
    Panel
    Ophthalmic
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    ENDOSOFT SOFT TIP NEEDLE (20 GA. AND 19 GA.)

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

    For irrigation/aspiration during eye surgery.

    Device Description

    The American Medical Devices, Inc 19 and 20 ga. Endosoft™ Soft Tip Needles are for irrigation/aspiration during eye surgery. The device consists of a stainless steel needle with a plastic luer lock on one end and a protruding piece of soft silastic tubing at the tip. This device connects to any conventional extrusion handpiece with a male luer lock adapter.

    AI/ML Overview

    This document is a 510(k) Premarket Notification summary for the American Medical Devices, Inc., 19 and 20 Ga. Endosoft™ Soft Tip Needles. It describes the device and claims substantial equivalence to predicate devices, but does not contain information about specific acceptance criteria or a study proving the device meets said criteria.

    Therefore, I cannot provide the requested information. The document focuses on demonstrating substantial equivalence based on device characteristics, indications for use, materials, and sterilization methods, rather than performance metrics.

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