IWJ · Class I · 21 CFR 892.5650

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

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

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 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 Aug 17, 1994
COOK BRACH NEEDLE/RADIO DELIV CATH/FLEXI FLEXICATH
K940550
Cook, Inc.
Radiology · 191d
Cleared Oct 13, 1992
QUICK SEEDER
K913293
Mick Radio-Nuclear Instruments, Inc.
Radiology · 447d
Cleared Apr 14, 1989
WANG FRONT LOADING APPLICATOR
K890485
Mick Radio-Nuclear Instruments, Inc.
Radiology · 73d
Cleared Apr 14, 1989
HILARIS-NORI CERVIX APPLICATOR
K891377
Mick Radio-Nuclear Instruments, Inc.
Radiology · 36d
Cleared Mar 14, 1989
MICK 200-TP AND MICK TP NEEDLE
K890341
Mick Radio-Nuclear Instruments, Inc.
Radiology · 50d
Cleared Feb 06, 1989
HANDLING & CUTTING DEVICE FOR IRIDIUM-192 WIRE PIN
K890191
Amersham Corp.
Radiology · 19d
Cleared Jul 21, 1987
HILARIS-NORI ENDOMETRIAL APPLICATOR
K871216
Mick Radio-Nuclear Instruments, Inc.
Radiology · 117d
Cleared Jul 16, 1987
KUMAR CERVICAL APPLICATOR
K871213
Mick Radio-Nuclear Instruments, Inc.
Radiology · 112d
Cleared Jul 16, 1987
HENSCHKE AFTERLOADING APPLICATOR
K871217
Mick Radio-Nuclear Instruments, Inc.
Radiology · 112d
Cleared Mar 26, 1985
I-125 IMPLANT GUN
K850571
Mick Radio-Nuclear Instruments, Inc.
Radiology · 41d
Cleared Oct 23, 1980
SCOTT NEEDLE & SCOTT MICK IMPLANTER
K801983
Mick Radio-Nuclear Instruments, Inc.
Radiology · 65d
Cleared Mar 25, 1980
CESIUM-137 AFTERLOADING SYSTEM /GYN.BRA.
K800320
Amersham Corp.
Radiology · 42d

About Product Code IWJ - Regulatory Context