KXK · Class II · 21 CFR 892.5730

FDA Product Code KXK: Source, Brachytherapy, Radionuclide

Leading manufacturers include Worldwide Medical Technologies, LLC, Implant Sciences Corp. and Cp Medical.

151
Total
151
Cleared
131d
Avg days
1980
Since
151 devices
25–48 of 151
Cleared May 02, 2014
BRACHYSOURCE SEED IMPLANTS WITH SOURCECAP BIOABSORBABLE CAPS
K140856
C.R. Bard, Inc.
Radiology · 29d
Cleared Jan 02, 2014
SPEC MODEL M15
K132969
Source Production & Equipment Co., Inc.
Radiology · 101d
Cleared Dec 17, 2013
CESITRX, (LIQUID CESIUM-131 SOLUTION) FOR USE WITH GLIASITE RTS
K132996
Isoray, Inc.
Radiology · 84d
Cleared Nov 20, 2013
MRI MARKER
K131689
C4 Imaging, LLC
Radiology · 163d
Cleared Jan 09, 2013
BEST LOCALIZATION NEEDLE WITH I-125 SEED
K122704
Best Medical Intl.
Radiology · 127d
Cleared Dec 28, 2012
RAPID STRAND RX
K122764
Medi-Physics, Inc.
Radiology · 109d
Cleared Aug 10, 2012
ADVANTAGE-STRAND/ADVANTAGE-LOAD BRACHYTHERAPY KIT
K113210
Isoaid, LLC
Radiology · 283d
Cleared Apr 19, 2012
PRE-LOADED GOLD VISICOIL CK MARKER
K120859
Radiomed Corporation
Radiology · 28d
Cleared Oct 18, 2011
RADIOACTIVE SEED LOCALIZATION NEEDLE
K111979
Biocompatibles, Inc.
Radiology · 98d
Cleared Aug 05, 2011
GLIASITE RTS
K111931
Isoray Medical, Inc.
Radiology · 28d
Cleared Jun 02, 2011
AOS ORION IR-192 SOURCE CABLE
K102811
Alpha-Omega Services, Inc.
Radiology · 247d
Cleared Feb 25, 2011
BRACHYTHERAPY NEEDLES, RP SLEEVE, RP BRACHY-SPACER, GOLD MAKERS
K103449
Riverpoint Medical
Radiology · 94d
Cleared Jan 03, 2011
I-SEED
K103319
Theragenics Corp.
Radiology · 52d
Cleared May 21, 2010
SYNTHETIC SEEDING SPACER MODEL SS9 X 50-50, SS9 X 55-50, SS9 X 55-150, SS9 X 1CM-30
K100847
Biocompatibles, Inc.
Radiology · 57d
Cleared Dec 23, 2009
RADIONUCLIDE BRACHYTHERAPY SOURCE
K093663
C.R. Bard, Inc.
Radiology · 28d
Cleared Nov 20, 2009
ACU007S
K092522
Oncology Systems, Inc.
Radiology · 94d
Cleared Sep 15, 2009
ADVANTAGE-STRAND/ ADVANTAGE-LOAD BRACHYTHERAPY KIT, MODEL IASLBKA
K091117
Isoaid, LLC
Radiology · 151d
Cleared Aug 28, 2009
PROXCELAN CS-131PRELOADED STRANDS, MODEL PL-1, PROXCELAN CS-131 PRELOADED STRANDS IN 18 GUAGE NEEDLES, MODEL PL-2
K092458
Isoray Medical, Inc.
Radiology · 17d
Cleared Aug 07, 2009
PROXCELAN CS-131 PRELOADED BRAIDED STRANDS, MODEL: PL-5
K092136
Isoray Medical, Inc.
Radiology · 23d
Cleared Apr 22, 2009
SPEC MODEL M-31
K090366
Source Production & Equipment Co., Inc.
Radiology · 68d
Cleared Jan 08, 2009
WORLDWIDE MEDICAL TECHNOLOGIES ANCHOR MARKER, MARKER STRAND AND MARKER
K083274
Biocompatibles, Inc.
Radiology · 63d
Cleared Sep 30, 2008
CIVASTRING PD-103
K082159
Civatech Oncology, Inc.
Radiology · 61d
Cleared Sep 26, 2007
POIINT OF CARE STRANDING SYSTEM, MODE 1004-00
K072296
Theragenics Corp.
Radiology · 40d
Cleared Jul 18, 2007
PRE-WAXED NEEDLES WITH GOLD FIDUCIARY MARKERS
K071550
Cp Medical
Radiology · 42d