KXK · Class II · 21 CFR 892.5730

FDA Product Code KXK: Source, Brachytherapy, Radionuclide

Leading manufacturers include Cp Medical, C.R. Bard, Inc. and Syncor Pharmaceuticals, Inc..

151
Total
151
Cleared
131d
Avg days
1980
Since
151 devices
49–72 of 151
Cleared Jan 26, 2005
THERALOAD CUSTOM LOADED NEEDLES, MODELS 200 AND 125.S06
K043596
Theragenics Corp.
Radiology · 28d
Cleared Jan 21, 2005
OPTISTRAND, MODEL 1032S
K043336
Ibt SA
Radiology · 49d
Cleared Jan 06, 2005
IMPLANT SCIENCES CORP, MODEL HDR-4140
K042864
Implant Sciences Corp.
Radiology · 80d
Cleared Dec 09, 2004
BEST RADIOPAQUE STRAND
K043117
Best Medical International, Inc.
Radiology · 29d
Cleared Nov 18, 2004
BEST MODEL # 81-01 SERIES IR-192 SOURCES
K042786
Best Medical International, Inc.
Radiology · 43d
Cleared Jul 16, 2004
EZ-PAK (EZ-PAK IS A TRADEMARK OF IBT S.A.)
K041702
Ibt SA
Radiology · 24d
Cleared Jul 02, 2004
SOURCELINK
K041576
C.R. Bard, Inc.
Radiology · 21d
Cleared Jan 30, 2004
CP SLEEVE AND RIVER SLEEVE
K034062
Cp Medical
Radiology · 30d
Cleared May 21, 2003
VARISEED 7.1
K030534
Varian Medical Systems
Radiology · 90d
Cleared Mar 12, 2003
GAMMAMED 212 AND 232 SOURCE ASSEMBLY
K030745
Varian Medical Systems
Radiology · 2d
Cleared Jul 13, 2002
SYNTHETIC ABSORBABLE SEEDING SPACERS MADE OF POLYDIOXANONE MATERIAL
K021311
Cp Medical
Radiology · 79d
Cleared Feb 22, 2002
CP-SLEEVE
K013975
Cp Medical
Radiology · 81d
Cleared Jan 24, 2002
MODIFICATION TO ACCU-SPACE PLAIN GUT ABSORBABLE SEEDING SPACERS
K013964
Cp Medical
Radiology · 52d
Cleared Sep 04, 2001
ACCU-SPACE ABSORBABLE SEEDING SPACERS
K010621
Cp Medical
Radiology · 187d
Cleared Feb 02, 2001
SELECT SEED I-125
K002429
Nucletron Corp.
Radiology · 178d
Cleared Sep 07, 2000
LOOK COLLAGEN SPACERS, MODEL 1514B
K001765
Surgical Specialties Corp
Radiology · 87d
Cleared Jul 17, 2000
PHARMASEED, MODEL BT-125-3
K994018
Syncor Pharmaceuticals, Inc.
Radiology · 234d
Cleared Jul 14, 2000
PHARMASEED, MODEL BT-103-3
K994016
Syncor Pharmaceuticals, Inc.
Radiology · 231d
Cleared Jun 09, 2000
PHARMASEED, MODEL BT-125-2
K993701
Syncor International, Inc.
Radiology · 220d
Cleared Jun 02, 2000
PHARMASEED, MODEL BT-103-2
K993700
Syncor International, Inc.
Radiology · 213d
Cleared Mar 31, 2000
ISOSEED PD-103
K993552
Bebig Isotopentechnik GmbH
Radiology · 163d
Cleared Mar 21, 2000
I-PLANT, MODEL 3500
K994317
Implant Sciences Corp.
Radiology · 90d
Cleared Mar 16, 2000
125-IMPLANT SEEDS, MODEL STM1250
K991881
Sourcetech Medical, LLC
Radiology · 288d
Cleared Mar 14, 2000
PROSTEC 125I BRACHYTHERAPY SEEDS
K993280
Prostec, LLC
Radiology · 166d