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510(k) Data Aggregation

    K Number
    K010166
    Device Name
    IMAGYN ISOSLEEVE / ISOSTAR NEEDLE SYSTEM
    Manufacturer
    IMAGYN MEDICAL TECHNOLOGIES, INC.
    Date Cleared
    2001-12-03

    (319 days)

    Product Code
    IWJ
    Regulation Number
    892.5650
    Why did this record match?
    Product Code :

    IWJ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K980997
    Device Name
    PGK DEVICE (MODIFIED)
    Manufacturer
    PGK, INC.
    Date Cleared
    1998-09-28

    (195 days)

    Product Code
    IWJ
    Regulation Number
    892.5650
    Why did this record match?
    Product Code :

    IWJ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Precise three-dimensional placement of needles into a sterile Field of the human body for diagnostic and therapeutic purposes, including brachytherapy for prostate cancer
    Device Description
    The modified PGK device includes a stereotactic bridge made of stainless steel and an aluminum protractor, which is attached to the bridge. The template in the modified PGK device, which substitutes the guidance device in the predicate PGK, is made of teflon. A post and bracket attachment to the template is made of stainless steel. The modified PGK is manufactured by Associated Design and Manufacturing (Registration #1122860) at 814 N. Henry St., Alexandria, Virginia.
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    K Number
    K972554
    Device Name
    REGANES RADIONUCLIDE SEED MAGAZINE
    Manufacturer
    AVID N.I.T., INC.
    Date Cleared
    1998-02-17

    (224 days)

    Product Code
    IWJ
    Regulation Number
    892.5650
    Why did this record match?
    Product Code :

    IWJ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A single patient use disposable device to hold radioactive seeds, in magazine fashion, in the MICK radionuclear 200-TP applicator. This device performs the same function as the reusable magazines sold by Mick Radionuclear Instruments, Inc.
    Device Description
    A single patient use disposable device to hold radioactive seeds, in magazine fashion, in the MICK radionuclear 200-TP applicator.
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    K Number
    K973037
    Device Name
    N.I.T., INC. RADIONUCLIDE SEED APPLICATOR, MODEL SA-1000
    Manufacturer
    AVID N.I.T., INC.
    Date Cleared
    1998-01-27

    (166 days)

    Product Code
    IWJ
    Regulation Number
    892.5650
    Why did this record match?
    Product Code :

    IWJ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The N.T., Inc. Radionuclide Seed Applicator is a manually operated device intended to apply a radionuclide source into the body for radiation therapy. This device is typically used in the transperineal approach for radionuclide seed application in the prostate.
    Device Description
    The N.T., Inc. Radionuclide Seed Applicator is a manually operated device intended to apply a radionuclide source into the body for radiation therapy.
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    K Number
    K974118
    Device Name
    WORLDWIDE MEDICAL TECHNOLOGIES SEED IMPLANT NEEDLE SET
    Manufacturer
    WORLDWIDE MEDICAL TECHNOLOGIES, LLC
    Date Cleared
    1998-01-23

    (84 days)

    Product Code
    IWJ
    Regulation Number
    892.5650
    Why did this record match?
    Product Code :

    IWJ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended use of the Worldwide Medical Technologies Seed Implant Needle is to introduce radionuclide seeds of I-125 or Pd-103 (purchased by the user directly from another manufacturer) into the body for radiation therapy. This device is typically used in the transperineal approach for radionuclide seed application in the prostate.
    Device Description
    Worldwide Medical Technologies Seed Implant Needle Set
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    K Number
    K973786
    Device Name
    NORTHWEST RADIATION THERAPY PRODUCTS, PRECISION STEPPER AND GUIDE
    Manufacturer
    NW RADIATION THERAPY PRODUCTS
    Date Cleared
    1998-01-02

    (88 days)

    Product Code
    IWJ
    Regulation Number
    892.5650
    Why did this record match?
    Product Code :

    IWJ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Precision Stepper and Needle Guide is intended for use with a rectal probe in ultrasound-guided prostate brachytherapy (transperineal radioactive seed implantation), and prostate gland voluming. The Precision Stepper and Needle Guide system is an accessory to an ultrasound system used for these medical procedures in a clinical setting. Condition to be screened, monitored, treated or diagnosed. Prostate gland voluming and treatment of prostate cancer by transperineal brachytherapy Physiological purpose. The Precision Stepper provides equipment support and quidance for a rectal probe. When used with its Needle Guide, an ultrasonic imaging system, and a rectal probe, the Precision Stepper and Needle Guide System is an accessory to clinical procedures for prostate gland voluming and ultrasound-guided radioactive seed implantation.
    Device Description
    The Precision Stepper and Needle Guide is a manually operated medical device used to provide mechanical support for the application of a radionuclide source into the prostate in the course of a brachytherapy procedure in a clinical setting. The Stepper guides and secures a rectal probe which is used for imaging of the prostate. The Stepper moves the transducer in precise increments, or steps. When used in conjunction with the Stepper, the Needle Guide is used to aid the clinician in guiding needles through a template into the prostate. Under the guidance of the ultrasound probe, these needles are used to implant radioactive seeds that irradiate the prostate in cancer therapy.
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    K Number
    K973638
    Device Name
    N.I.T., INC. NEEDLE GUIDING TEMPLATE
    Manufacturer
    AVID N.I.T., INC.
    Date Cleared
    1997-12-23

    (90 days)

    Product Code
    IWJ
    Regulation Number
    892.5650
    Why did this record match?
    Product Code :

    IWJ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The N.I.T., Inc. Needle Guiding Template is a device with needle guidance holes in a grid for the placement of radionuclide seeds into the body. Coordinate system assure to place the template in proximity to, but not touching the perineum for seed placement into and around the prostate.
    Device Description
    The N.I.T., Inc. Needle Guiding Template is a device with needle guidance holes in a grid
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    K Number
    K973184
    Device Name
    PROSTATE SEEDING NEEDLE
    Manufacturer
    PROMEX, INC.
    Date Cleared
    1997-11-21

    (88 days)

    Product Code
    IWJ
    Regulation Number
    892.5650
    Why did this record match?
    Product Code :

    IWJ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For the manual application of a radionuclide source into the body for radiation therapy.
    Device Description
    Prostate Seeding Needle
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    K Number
    K963743
    Device Name
    MANAN PROSTATE UNI-LOCK
    Manufacturer
    MANAN MEDICAL PRODUCTS, INC.
    Date Cleared
    1996-12-06

    (80 days)

    Product Code
    IWJ
    Regulation Number
    892.5650
    Why did this record match?
    Product Code :

    IWJ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K951052
    Device Name
    WEEKS APPLICATOR
    Manufacturer
    DUKE UNIVERSITY MEDICAL CENTER
    Date Cleared
    1996-08-22

    (535 days)

    Product Code
    IWJ
    Regulation Number
    892.5650
    Why did this record match?
    Product Code :

    IWJ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question

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