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510(k) Data Aggregation

    K Number
    K965256
    Device Name
    DMS-1000C DERMOABRADER
    Manufacturer
    MATTIOLI ENGINEERING, SRL
    Date Cleared
    1996-12-09

    (115 days)

    Product Code
    GFD
    Regulation Number
    878.4820
    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
    Device Description
    AI/ML Overview
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    K Number
    K962371
    Device Name
    DERMTOME BLADE
    Manufacturer
    DSP WORLDWIDE
    Date Cleared
    1996-08-29

    (71 days)

    Product Code
    GFD
    Regulation Number
    878.4820
    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 DSP Worldwide Snowden-Pencer Dermatome Blade is intended for use as an accessory to Padgett type dermatomes.

    Device Description

    The DSP Worldwide Snowden-Pencer Dermatome Blade is secured to the Padgett Dermatome head using the securing nut. The blade oscillates on the horizontal plane to harvest a split thickness of skin from a donor site for grafting. It is provided in one size only and consists of the stainless steel used for many surgical applications. Blades are provided sterile, single use, and disposable in individual Tyvek and polypropylene pouches. Devices are sterilized using gamma sterilization.

    AI/ML Overview

    I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance, a study, sample sizes, data provenance, ground truth, expert qualifications, adjudication methods, or comparative effectiveness studies. The document only describes a dermatome blade, its intended use, and claims equivalence to a predicate device.

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