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Found 11 results
510(k) Data Aggregation
K Number
K010166Device Name
IMAGYN ISOSLEEVE / ISOSTAR NEEDLE SYSTEM
Manufacturer
IMAGYN MEDICAL TECHNOLOGIES, INC.
Date Cleared
2001-12-03
(319 days)
Product Code
IWJ
Regulation Number
892.5650Why 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
K980997Device Name
PGK DEVICE (MODIFIED)
Manufacturer
PGK, INC.
Date Cleared
1998-09-28
(195 days)
Product Code
IWJ
Regulation Number
892.5650Why 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
K972554Device Name
REGANES RADIONUCLIDE SEED MAGAZINE
Manufacturer
AVID N.I.T., INC.
Date Cleared
1998-02-17
(224 days)
Product Code
IWJ
Regulation Number
892.5650Why 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
K973037Device 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
892.5650Why 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
K974118Device 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
892.5650Why 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
K973786Device 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
892.5650Why 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
K973638Device 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
892.5650Why 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
K973184Device Name
PROSTATE SEEDING NEEDLE
Manufacturer
PROMEX, INC.
Date Cleared
1997-11-21
(88 days)
Product Code
IWJ
Regulation Number
892.5650Why 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
K963743Device Name
MANAN PROSTATE UNI-LOCK
Manufacturer
MANAN MEDICAL PRODUCTS, INC.
Date Cleared
1996-12-06
(80 days)
Product Code
IWJ
Regulation Number
892.5650Why 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
K951052Device Name
WEEKS APPLICATOR
Manufacturer
DUKE UNIVERSITY MEDICAL CENTER
Date Cleared
1996-08-22
(535 days)
Product Code
IWJ
Regulation Number
892.5650Why 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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