Product code KXK— Radiology
GammaTile
- Classification name
- Source, Brachytherapy, Radionuclide
- Device class
- Class 2
- Regulation
- 21 CFR 892.5730
- Advisory panel
- Radiology
- Total cleared
- 151
- First cleared
- Most recent
Market context for product code KXK
FDA has cleared devices under product code KXK between 1980 and 2025, filed by 79 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
last 15 years- 2025
- 2023
- 2022
- 2020
- 2019
- 2018
- 2017
- 2016
- 2015
- 2014
- 2013
- 2012
- 2011
- 2010
- 2009
Top applicants under product code KXK
Recent clearances under product code KXK
1–100 of 151- K252296 — OncoPatch
- K242818 — IsoSphere
- K223465 — RadianceTx Radionuclide Brachytherapy Source
- K221539 — GammaTile
- K202267 — Sirius MRI Markers, Cs-131 Preloaded Strands with Sirius MRI Markers in 18 Gauge Needles
- K193602 — LV Liberty Vision Model 1 90Yttrium Brachytherapy Source
- K190839 — GammaTile
- K191324 — CivaDerm
- K190296 — GammaTile
- K180515 — GammaTile
- K171487 — Sirius MRI Marker NS
- K163572 — LV Liberty Vision Model 1 90 Yttrium Brachytherapy Source
- K163206 — SMD-Sr90-DA Radionuclide Brachytherapy Source
- K162573 — Source Production & Equipment Co., Inc. Model M14 192Iridium Brachytherapy Source
- K161396 — SPEC Model M23
- K161395 — SPEC Model M13
- K150895 — SPEC Model M16
- K150636 — VariSeed 9.0
- K142701 — SMD Sr90-1 Radionuclide Brachytherapy Source
- K141701 — I-125 RSLN [RADIOACTIVE SEED AND LOCALIZATION NEEDLE]
- K142668 — Lesion-Loc Iodine I-125 Seed/Needle
- K141038 — ANT MODEL 1
- K140490 — CIVA SHEET PD-103
- K140849 — ISOSEED
- K140856 — BRACHYSOURCE SEED IMPLANTS WITH SOURCECAP BIOABSORBABLE CAPS
- K132969 — SPEC MODEL M15
- K132996 — CESITRX, (LIQUID CESIUM-131 SOLUTION) FOR USE WITH GLIASITE RTS
- K131689 — MRI MARKER
- K122704 — BEST LOCALIZATION NEEDLE WITH I-125 SEED
- K122764 — RAPID STRAND RX
- K113210 — ADVANTAGE-STRAND/ADVANTAGE-LOAD BRACHYTHERAPY KIT
- K120859 — PRE-LOADED GOLD VISICOIL CK MARKER
- K111979 — RADIOACTIVE SEED LOCALIZATION NEEDLE
- K111931 — GLIASITE RTS
- K102811 — AOS ORION IR-192 SOURCE CABLE
- K103449 — BRACHYTHERAPY NEEDLES, RP SLEEVE, RP BRACHY-SPACER, GOLD MAKERS
- K103319 — I-SEED
- K100847 — SYNTHETIC SEEDING SPACER MODEL SS9 X 50-50, SS9 X 55-50, SS9 X 55-150, SS9 X 1CM-30
- K093663 — RADIONUCLIDE BRACHYTHERAPY SOURCE
- K092522 — ACU007S
- K091117 — ADVANTAGE-STRAND/ ADVANTAGE-LOAD BRACHYTHERAPY KIT, MODEL IASLBKA
- K092458 — PROXCELAN CS-131PRELOADED STRANDS, MODEL PL-1, PROXCELAN CS-131 PRELOADED STRANDS IN 18 GUAGE NEEDLES, MODEL PL-2
- K092136 — PROXCELAN CS-131 PRELOADED BRAIDED STRANDS, MODEL: PL-5
- K090366 — SPEC MODEL M-31
- K083274 — WORLDWIDE MEDICAL TECHNOLOGIES ANCHOR MARKER, MARKER STRAND AND MARKER
- K082159 — CIVASTRING PD-103
- K072296 — POIINT OF CARE STRANDING SYSTEM, MODE 1004-00
- K071550 — PRE-WAXED NEEDLES WITH GOLD FIDUCIARY MARKERS
- K062825 — AOS MARKER SEEDS
- K070468 — IMPLANT SCIENCES CORP. MODEL HDR 4454
- K062214 — BRACHYSCIENCES STRANDPORT
- K063177 — RAPID STRAND RX
- K062384 — CESIUM-131 STRAND, STRAND PRELOAD, PRELOAD, S-CARTRIDGE
- K061638 — BEST STRAND AND BEST SPACER
- K060679 — SURTRAK IMPLANTATION KIT
- K060636 — PALLADIUM-103 SEED IMPLANT KITS -MULTIPLE
- K053595 — CURAY CUSTOM SEED ARRAY
- K052024 — NSTRAND IMPLANTATION KIT
- K043246 — BRACHYSOURCE BRACHYTHERAPY SEED IMPLANTS
- K043596 — THERALOAD CUSTOM LOADED NEEDLES, MODELS 200 AND 125.S06
- K043336 — OPTISTRAND, MODEL 1032S
- K042864 — IMPLANT SCIENCES CORP, MODEL HDR-4140
- K043117 — BEST RADIOPAQUE STRAND; BEST RADIOPAQUE MARKER
- K042786 — BEST MODEL # 81-01 SERIES IR-192 SOURCES
- K040766 — OPTISOURCE, MODEL 1032P
- K041702 — EZ-PAK (EZ-PAK IS A TRADEMARK OF IBT S.A.)
- K041576 — SOURCELINK
- K033770 — ISOAID ADVANTAGE PD-103, MODEL IAPD-103A
- K040339 — BRACHYTHERAPY STRAND DEVICE
- K034062 — CP SLEEVE AND RIVER SLEEVE
- K033781 — BEBIG ISOSEED I-125
- K023179 — READI-STRAND, MODEL PSSTRAND
- K021360 — SCINTILLATING FIBER DOSIMETER (SFD), MODEL MT-SFD-1000
- K022705 — READI-STRAND, MODEL PSSTRAND
- K030534 — VARISEED 7.1
- K022389 — READI-LOAD SYSTEM, MODEL PSS 1820RL
- K030594 — I-125 RAPID STRAND, MODEL 7000
- K023073 — SEED LINK
- K023210 — SEEDLINKS, MODELS 70301, 70302, 70303
- K030162 — LAWRENCE CSERION, MODEL CS-1
- K024183 — ALTON PT STEPPER
- K030745 — GAMMAMED 212 AND 232 SOURCE ASSEMBLY
- K010705 — OPTIDOS
- K020683 — ISOROD PD-103 IMPLANT, MODEL ATI-PD-103
- K023242 — I-PLANT MODEL 3500 (125IODINE BRACHYTHERAPY SEEDS)-STERILE
- K020337 — READI-STRAND; MODEL PSSTRAND
- K021311 — SYNTHETIC ABSORBABLE SEEDING SPACERS MADE OF POLYDIOXANONE MATERIAL
- K021343 — ISOSEEDS I-125
- K013975 — CP-SLEEVE
- K013964 — MODIFICATION TO ACCU-SPACE PLAIN GUT ABSORBABLE SEEDING SPACERS
- K013660 — GENETRA
- K010621 — ACCU-SPACE ABSORBABLE SEEDING SPACERS
- K011427 — MBI PD-103 SL; MBI PD-103 SH
- K011155 — INTERSTRAND 125 & INTERSTRAND 103, MODEL NUMBERS 1251S AND 1031S
- K011205 — ISOAID IODINE BRACHTHERAPY SEEDS, MODEL ADVANTAGE I-125
- K011119 — BRACHYSEED PD-103 MODELS #PD1
- K010283 — THERASEED(R) PALLADIUM-103 IMPLANT; MODEL 200
- K003206 — GLIASITE RADIATION THERAPY SYSTEM (RTS), MODEL 1020,1030,1040,8150,9005
- K010821 — ECHOSEED/IODINE-125 SEEDS, MODEL 6733
- K002429 — SELECT SEED I-125
Data sourced from openFDA. This site is unofficial and independent of the FDA.