FDA 510(k) Applications for Medical Device Product Code "IWJ"
(System, Applicator, Radionuclide, Manual)

FDA 510(k) Number Applicant Device Name Decision Date
K973638 AVID N.I.T., INC. N.I.T., INC. NEEDLE GUIDING TEMPLATE 12/23/1997
K973037 AVID N.I.T., INC. N.I.T., INC. RADIONUCLIDE SEED APPLICATOR, MODEL SA-1000 01/27/1998
K972554 AVID N.I.T., INC. REGANES RADIONUCLIDE SEED MAGAZINE 02/17/1998
K951052 DUKE UNIVERSITY MEDICAL CENTER WEEKS APPLICATOR 08/22/1996
K010166 IMAGYN MEDICAL TECHNOLOGIES, INC. IMAGYN ISOSLEEVE / ISOSTAR NEEDLE SYSTEM 12/03/2001
K961377 MANAN MEDICAL PRODUCTS, INC. MANAN PROSTATE LOCKING INTRODUCER SET 07/03/1996
K963743 MANAN MEDICAL PRODUCTS, INC. MANAN PROSTATE UNI-LOCK 12/06/1996
K973786 NW RADIATION THERAPY PRODUCTS NORTHWEST RADIATION THERAPY PRODUCTS, PRECISION STEPPER AND GUIDE 01/02/1998
K980997 PGK, INC. PGK DEVICE (MODIFIED) 09/28/1998
K973184 PROMEX, INC. PROSTATE SEEDING NEEDLE 11/21/1997
K974118 WORLDWIDE MEDICAL TECHNOLOGIES, LLC WORLDWIDE MEDICAL TECHNOLOGIES SEED IMPLANT NEEDLE SET 01/23/1998


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