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510(k) Data Aggregation

    K Number
    K984382
    Device Name
    ACCU GUIDE
    Manufacturer
    TAYMAN MEDICAL, INC.
    Date Cleared
    1999-03-05

    (87 days)

    Product Code
    IYO
    Regulation Number
    892.1560
    Why did this record match?
    Applicant Name (Manufacturer) :

    TAYMAN MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Tayman Medical AccuGuide is used to mount disposable 18 gauge x 20 centimeter automated biopsy needles to the CLI 4900 Utrasound Probe manufactured by Capistrano Labs for the purpose of accurately guiding the needle to the site where the biopsy sample is to be taken.
    Device Description
    Tayman Medical Inc., AccuGuide comprises a steel spring mounting clip, a stainless steel mounting tab and a stainless steel biopsy needle guide tube. The Tayman Medical AccuGuide is comprised of three basic components: the probe clamp, the mounting tab, and the biopsy needle guide tube. Probe Clamp - the probe clamp is made of medical grade hard chrome plated steel it provides a spring force to hold the Tayman Medical AccuGuide to the ultrasound probe. The probe clamp does not contact the patient. Mounting Tab - the mounting tab is made of stainless steel. It provides a common joining point for the other components and acts as a stabilizer between the Tayman Medical AccuGuide and the ultrasound probe. The mounting tab does not contact the patient. Biorsy Needle Guide Tube - the biopsy needle guide tube is made of stainless steel. It guides the needle along the predetermined path. This component contact intact tissue. This component is designed in a low profile with a smooth, rounded tip.
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    K Number
    K963302
    Device Name
    TAYMAN MEDICAL, INC. STEPPING & STABILIZING SYSTEM
    Manufacturer
    TAYMAN MEDICAL, INC.
    Date Cleared
    1997-02-06

    (168 days)

    Product Code
    ITX
    Regulation Number
    892.1570
    Why did this record match?
    Applicant Name (Manufacturer) :

    TAYMAN MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Tayman Medical, Inc. Stepping and Stabilization System is used to provide precision ultrasound probe alignment and radioactive seed implantation in the treatment of prostate cancer.
    Device Description
    The seeding device is comprised of three basic components. The adjustable height base. The adjustable, multi-axis head. The ultrasound probe holder and needle guide.
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