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510(k) Data Aggregation

    K Number
    K970875
    Device Name
    ENDOLIGHT FIBEROPTIC ENDO-ILLUMINATOR (20 GA. & 19 GA.)
    Manufacturer
    AMERICAN MEDICAL DEVICES, INC.
    Date Cleared
    1997-05-20

    (71 days)

    Product Code
    MPA,HQE
    Regulation Number
    876.1500
    Type
    Traditional
    Panel
    Ophthalmic
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    ENDOLIGHT FIBEROPTIC ENDO-ILLUMINATOR (20 GA. & 19 GA.)

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

    For illumination during ophthalmic surgery

    Device Description

    The American Medical Devices, Inc., 19 and 20 ga. Endolight™ Fiberoptic Endo- Illuminators are for illumination during ophthalmic surgery. The device consists of a stainless steel needle with a delrin handpiece, PMMA fiberoptic fiber with plastic cladding and an aluminum connector. This device connects to any conventional light source via an aluminum accessory adapter, which is packaged separately.

    AI/ML Overview

    This 510(k) summary (K970875) describes a fiberoptic endo-illuminator. However, the document does not contain information regarding acceptance criteria or a study proving the device meets specific acceptance criteria.

    The provided text focuses on:

    • Device Description: The physical characteristics and materials of the Endolight™ Fiberoptic Endo-Illuminator.
    • Indications for Use: For illumination during ophthalmic surgery.
    • Substantial Equivalence Comparison: A table comparing the device's features (packaging, indication, materials, sterilization) to predicate devices (Storz, Grieshaber & Co) to demonstrate substantial equivalence.
    • Sterility Information: Details on ETO sterilization, packaging, SAL, and residue levels, as well as pyrogenicity testing (LAL method).
    • FDA Clearance Letter: Official communication from the FDA confirming the device's substantial equivalence and clearance to market.

    Therefore, I cannot provide the requested table and study details as they are not present in the provided document.

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