IWJ · Class I · 21 CFR 892.5650

FDA Product Code IWJ: System, Applicator, Radionuclide, Manual

Leading manufacturers include Mick Radio-Nuclear Instruments, Inc., Best Industries and Avid N.I.T., Inc..

36
Total
36
Cleared
147d
Avg days
1980
Since

FDA 510(k) Cleared System, Applicator, Radionuclide, Manual Devices (Product Code IWJ)

36 devices
1–24 of 36
Cleared Dec 03, 2001
IMAGYN ISOSLEEVE / ISOSTAR NEEDLE SYSTEM
K010166
Imagyn Medical Technologies, Inc.
Radiology · 319d
Cleared Sep 28, 1998
PGK DEVICE (MODIFIED)
K980997
Pgk, Inc.
Radiology · 195d
Cleared Feb 17, 1998
REGANES RADIONUCLIDE SEED MAGAZINE
K972554
Avid N.I.T., Inc.
Radiology · 224d
Cleared Jan 27, 1998
N.I.T., INC. RADIONUCLIDE SEED APPLICATOR, MODEL SA-1000
K973037
Avid N.I.T., Inc.
Radiology · 166d
Cleared Jan 23, 1998
WORLDWIDE MEDICAL TECHNOLOGIES SEED IMPLANT NEEDLE SET
K974118
Worldwide Medical Technologies, LLC
Radiology · 84d
Cleared Jan 02, 1998
NORTHWEST RADIATION THERAPY PRODUCTS, PRECISION STEPPER AND GUIDE
K973786
Nw Radiation Therapy Products
Radiology · 88d
Cleared Dec 23, 1997
N.I.T., INC. NEEDLE GUIDING TEMPLATE
K973638
Avid N.I.T., Inc.
Radiology · 90d
Cleared Nov 21, 1997
PROSTATE SEEDING NEEDLE
K973184
Promex, Inc.
Radiology · 88d
Cleared Dec 06, 1996
MANAN PROSTATE UNI-LOCK
K963743
Manan Medical Products, Inc.
Radiology · 80d
Cleared Aug 22, 1996
WEEKS APPLICATOR
K951052
Duke University Medical Center
Radiology · 535d
Cleared Jul 03, 1996
MANAN PROSTATE LOCKING INTRODUCER SET
K961377
Manan Medical Products, Inc.
Radiology · 84d
Cleared Feb 24, 1995
MORGANSTERN PROSTATE STABILIZATION AND SEEDING KIT
K944522
Medical Device Technologies, Inc.
Radiology · 161d
Cleared Dec 30, 1994
IMPLANT APPLICATORS, CARTRIDGES/MAGAZINES, IMPLANTERS FOR PERMANENT IMPLANT OF RADIOACTIVE SEEDS/SOURCES
K933410
Best Industries
Radiology · 533d
Cleared Dec 30, 1994
IMPLANTERS/ADJUSTABLE/ANDERSON'S MARKERS
K940121
Best Industries
Radiology · 354d
Cleared Aug 17, 1994
COOK BRACH NEEDLE/RADIO DELIV CATH/FLEXI FLEXICATH
K940550
Cook, Inc.
Radiology · 191d
Cleared Jun 04, 1993
BEST INDUSTRIES CARTRIDGE & GUN
K924290
Best Industries
Radiology · 287d
Cleared Oct 13, 1992
QUICK SEEDER
K913293
Mick Radio-Nuclear Instruments, Inc.
Radiology · 447d
Cleared Oct 05, 1992
NEEDLE TECHNOLOGIES SEED IMPLANT NEEDLE
K921886
Needle Technologies, Inc.
Radiology · 167d
Cleared Jul 01, 1992
SDMO APPLICATOR CODE: ASN.8236
K921961
Medi-Physics Inc. Dba Nycomed Amersham Imaging
Radiology · 65d
Cleared Apr 18, 1991
VARIOUS TEMPLATE APPLICATORS
K910862
Best Industries
Radiology · 48d
Cleared Jan 04, 1991
VARIOUS AFTERLOADING APPLICATORS
K904933
Best Assoc. Corp.
Radiology · 64d
Cleared Oct 01, 1990
CT-COMPATIBLE FLETCHER SYSTEM APPLICATOR
K903403
University of Michigan
Radiology · 62d
Cleared Jul 11, 1990
PLASTIC-GUIDES
K901842
M & K Co.
Radiology · 78d
Cleared Sep 18, 1989
AFTER LOADING DEVICE KIT
K893703
Medical Radiation Devices, Inc.
Radiology · 123d

About Product Code IWJ - Regulatory Context