KXK · Class II · 21 CFR 892.5730

FDA Product Code KXK: Source, Brachytherapy, Radionuclide

Leading manufacturers include Cp Medical, C.R. Bard, Inc. and Source Production and Equipment Co., Inc..

151
Total
151
Cleared
131d
Avg days
1980
Since
151 devices
73–96 of 151
Cleared Feb 22, 2000
10 CURIE IRDIUM 192, CSN00100-192
K991571
Alpha-Omega Services, Inc.
Radiology · 293d
Cleared Jan 14, 2000
PHARMASEED, MODEL BT-103-1
K992007
Syncor Pharmaceuticals, Inc.
Radiology · 213d
Cleared Dec 23, 1999
PHARMASEED, MODEL BT-125-1
K992008
Syncor Pharmaceuticals, Inc.
Radiology · 191d
Cleared Nov 05, 1999
WORLDWIDE MEDICAL TECHNOLOGIES SEEDING SPACERS
K991344
Worldwide Medical Technologies, LLC
Radiology · 200d
Cleared Oct 20, 1999
125 IMPLANT SEEDS, MODEL STM1251
K991280
Sourcetech Medical, LLC
Radiology · 189d
Cleared Oct 04, 1999
INDIGO PROSTATE SEEDING NEEDLE CARTRIDGE SYSTEM
K992262
Indigo Medical, Inc.
Radiology · 90d
Cleared Sep 21, 1999
I3RAD 125 I BRACHYTHERAPY SEED, MODEL I125-0401
K992963
International Isotopes, Inc.
Radiology · 19d
Cleared Jun 17, 1999
ISOSTAR I-125 INTERSTITIAL SEED, MODEL IS-12501
K991526
Imagyn Medical Technologies, Inc.
Radiology · 45d
Cleared Jun 09, 1999
INTERSOURCE 125, MODEL 1251L
K984235
International Brachytherapy, Inc.
Radiology · 196d
Cleared May 20, 1999
IODINE BRACHYTHERAPY SEEDS, MODEL 3000
K990193
Implant Sciences Corp.
Radiology · 119d
Cleared May 13, 1999
UROMED BRACHYTHERAPHY IODINE-125 SOURCES
K982226
Uromed Corp.
Radiology · 323d
Cleared Apr 16, 1999
`BI I-125 BRACHYTHERAPHY SEED, MODEL 125SL & 125SH
K984446
Urocor, Inc.
Radiology · 123d
Cleared Dec 10, 1998
INTERSOURCE
K973328
International Brachytherapy S.A.
Radiology · 462d
Cleared Oct 28, 1997
NORTH AMERICAN SCIENTIFIC (NASI) I-125 RADIONUCLIDE BRACHYTHERAPY SOURCE- MODEL MED 3631-A
K972271
Ml Strategies, Inc.
Radiology · 132d
Cleared Feb 10, 1997
NORTH AMERICAN SCIENTIFIC (NASI) 1-125 RADIONUCLIDE BRACHYTHERAPY SOURCE
K964647
North American Scientific, Inc.
Radiology · 82d
Cleared Dec 13, 1993
RADIONUCLIDE CATHETERS, RNC-A, RNC-G, RNC-U
K923697
Radionics, Inc.
Radiology · 507d
Cleared Aug 10, 1990
MANAN PROSTATE SEEDING NEEDLE
K902622
Manan Medical Products, Inc.
Radiology · 57d
Cleared Aug 21, 1985
CESIUM 137 ENDOMETRIAL SOURCE
K850433
Syncor Intl. Corp.
Radiology · 198d
Cleared Aug 21, 1985
CESIUM 137 SOURCE, CSM-4, CSM-11, CSM-41
K852023
Syncor Intl. Corp.
Radiology · 105d
Cleared Mar 26, 1985
CS137 SEALED SOURCES
K850434
Syncor Intl. Corp.
Radiology · 50d
Cleared Dec 18, 1980
3M I-125 SEEDS IN ABSORBABLE CARRIER
K801748
3M Company
Radiology · 143d