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510(k) Data Aggregation

    K Number
    K994015
    Device Name
    ACCUBLADE (ACS MODEL), MK8507, ACCUBLADE (HANSOTOME MODEL), MK8508
    Manufacturer
    SURGIN SURGICAL INSTRUMENTATION, INC.
    Date Cleared
    2000-03-15

    (110 days)

    Product Code
    HNO
    Regulation Number
    886.4370
    Type
    Traditional
    Panel
    Ophthalmic
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    ACCUBLADE (ACS MODEL), MK8507, ACCUBLADE (HANSOTOME MODEL), MK8508

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

    The Surgin Inc. AccuBlade(ACS Model MK8507 and Hansatome Model MK8508) are designed as replacement blades for the Chiron Vision Corp. Model ACS Keratomo and Chiron Hansatome microkeratome for lamellar resection of the cornea

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) premarket notification approval letter for the Surgin AccuBlade™ Microkeratome Blade, which primarily focuses on regulatory approval based on substantial equivalence to existing devices. It does not contain information about specific acceptance criteria for device performance, the details of a study that proves the device meets those criteria, or any of the other requested information regarding sample sizes, ground truth establishment, or clinical study methodologies.

    Therefore, I cannot provide the requested table and study details from the given text. The document is a regulatory approval notice, not a clinical study report.

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