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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