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510(k) Data Aggregation

    K Number
    K252060
    Device Name
    GREEN
    Manufacturer
    Phasor Health, LLC
    Date Cleared
    2025-10-31

    (122 days)

    Product Code
    HBE
    Regulation Number
    882.4310
    Type
    Traditional
    Panel
    Neurology
    Reference & Predicate Devices
    K211138,K161704
    Predicate For
    N/A
    Why did this record match?
    Reference Devices :

    K211138

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

    Phasor GREEN Drill is a re-sterilizable drill driver (for use on one ore more patients, up to 10 total holes), with separately packaged single-use sterilized drill bit assembly -- for use on adult patients during neurosurgical procedures for drilling of cranial bone.

    Device Description

    The Phasor™ GREEN Drill is composed of 2 items: (1) a re-sterilizable, non-rechargeable battery-operated Phasor Green Driver (made of plastic housing, capable of drilling up to 10 total holes in one or more patients) in conjunction with (2) a separately packaged, single-use Phasor Green Drill Bit Assembly comprised of a steel bit (of 6.35-mm or less), plastic adapter, and polybag secured using latex-free bands. The device is for drilling cranial or orthopedic bone, by prescription only and used by qualified users, with (1) Drill Driver (provided non-sterile) for sterilization using vaporized hydrogen peroxide (VHP)prior to use at user facility and (2) Drill Bit Assembly provided gamma-sterilized for single-use respectively.

    AI/ML Overview

    N/A

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