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510(k) Data Aggregation

    K Number
    K091462
    Device Name
    SPECTRA MEDICAL SAFETY SCAPEL
    Manufacturer
    SPECTRA, INC.
    Date Cleared
    2009-12-15

    (211 days)

    Product Code
    GDZ,GES
    Regulation Number
    878.4800
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Spectra Safety Scalpel is a surgical safety scalpel intended for use as a cutting device during surgical, pathology and minor medical procedures. It is intended to aid in the protection against accidental injuries during loading, passing, and disposal.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) premarket notification letter from the FDA regarding the Spectra Medical Safety Scalpel. It states that the device has been found substantially equivalent to legally marketed predicate devices.

    However, this document does not contain any information about acceptance criteria, device performance, study details (sample sizes, data provenance, ground truth establishment, expert qualifications, adjudication methods), or multi-reader multi-case studies. These are typical components of a technical study report that would accompany such a submission, but they are not present in this regulatory letter itself.

    Therefore,Based on the provided document, I cannot answer any of the questions regarding acceptance criteria and study details. The document is solely an FDA 510(k) clearance letter and does not include performance data or study methodology.

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