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    K Number
    K242228
    Device Name
    Triopsy Actuator (TMSDGB); Triopsy Biopsy Needle (BN-1825-36-01); Triopsy Biopsy Needle (BN-1825-55-01)
    Manufacturer
    Triopsy Medical, Inc.
    Date Cleared
    2025-01-10

    (164 days)

    Product Code
    KNW, FCG
    Regulation Number
    876.1075
    Why did this record match?
    Applicant Name (Manufacturer) :

    Triopsy Medical, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Triopsy Biopsy System (instrument and needles) is intended for use in obtaining biopsies from the prostate.
    Device Description
    The Triopsy Medical Actuator and Biopsy Needle is comprehensive system that aids in the diagnosis and treatment planning of prostate cancer. The system utilizes an actuator instrument and biopsy needle (disposable) with the intention of gathering prostate tissue and properly identifying its pathology. The needle collects full-length, unbroken apex-to-base core samples with patented ridges that hold and protect the sample's integrity. The actuator allows for variable sample lengths for each area of the prostate to be biopsied increasing accuracy and patient safety by avoiding under or overshooting.
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