FDA Browser
by
Innolitics
Anesthesiology
Review Panel
Cardiovascular
Review Panel
Chemistry
Review Panel
Dental
Review Panel
Ear, Nose, Throat
Review Panel
Gastroenterology and Urology
Review Panel
General Hospital
Review Panel
Hematology
Review Panel
Immunology
Review Panel
Microbiology
Review Panel
Neurology
Review Panel
Obstetrical and Gynecological
Review Panel
Ophthalmic
Review Panel
Orthopedic
Review Panel
Pathology
Review Panel
Physical Medicine
Review Panel
Radiology
Review Panel
Miscellaneous
Miscellaneous
Subpart B—Diagnostic Devices
CFR Sub-Part
Subpart C—Obstetrical and Gynecological Monitoring Devices
CFR Sub-Part
Subpart F—Therapeutic Devices
CFR Sub-Part
FCD
Barium Enema Kit
1
Product Code
ITZ
Assembly, Tube Housing, X-Ray, Therapeutic
2
Product Code
IWA
Source, Wire, Iridium, Radioactive
2
Product Code
IWB
System, Radiation Therapy, Radionuclide
2
Product Code
IWD
Device, Beam Limiting, Teletherapy, Radionuclide
2
Product Code
IWE
Monitor, Patient Position, Light-Beam
1
Product Code
IWF
Needle, Isotope, Gold, Titanium, Platinum
2
Product Code
IWG
Seed, Isotope, Gold, Titanium, Platinum
2
Product Code
IWH
Source, Teletherapy, Radionuclide
1
Product Code
IWI
Source, Isotope, Sealed, Gold, Titanium, Platinum
2
Product Code
IWJ
System, Applicator, Radionuclide, Manual
1
Product Code
K
01
0166
IMAGYN ISOSLEEVE / ISOSTAR NEEDLE SYSTEM
1
Cleared 510(K)
K
98
0997
PGK DEVICE (MODIFIED)
1
Cleared 510(K)
K
97
2554
REGANES RADIONUCLIDE SEED MAGAZINE
1
Cleared 510(K)
K
97
3037
N.I.T., INC. RADIONUCLIDE SEED APPLICATOR, MODEL SA-1000
1
Cleared 510(K)
K
97
4118
WORLDWIDE MEDICAL TECHNOLOGIES SEED IMPLANT NEEDLE SET
1
Cleared 510(K)
K
97
3786
NORTHWEST RADIATION THERAPY PRODUCTS, PRECISION STEPPER AND GUIDE
1
Cleared 510(K)
K
97
3638
N.I.T., INC. NEEDLE GUIDING TEMPLATE
1
Cleared 510(K)
K
97
3184
PROSTATE SEEDING NEEDLE
1
Cleared 510(K)
K
96
3743
MANAN PROSTATE UNI-LOCK
1
Cleared 510(K)
K
95
1052
WEEKS APPLICATOR
1
Cleared 510(K)
K
96
1377
MANAN PROSTATE LOCKING INTRODUCER SET
1
Cleared 510(K)
K
94
4522
MORGANSTERN PROSTATE STABILIZATION AND SEEDING KIT
1
Cleared 510(K)
K
94
0121
IMPLANTERS/ADJUSTABLE/ANDERSON'S MARKERS
1
Cleared 510(K)
K
93
3410
IMPLANT APPLICATORS, CARTRIDGES/MAGAZINES, IMPLANTERS FOR PERMANENT IMPLANT OF RADIOACTIVE SEEDS/SOURCES
1
Cleared 510(K)
K
94
0550
COOK BRACH NEEDLE/RADIO DELIV CATH/FLEXI FLEXICATH
1
Cleared 510(K)
K
92
4290
BEST INDUSTRIES CARTRIDGE & GUN
1
Cleared 510(K)
K
91
3293
QUICK SEEDER
1
Cleared 510(K)
K
92
1886
NEEDLE TECHNOLOGIES SEED IMPLANT NEEDLE
1
Cleared 510(K)
K
92
1961
SDMO APPLICATOR CODE: ASN.8236
1
Cleared 510(K)
K
91
0862
VARIOUS TEMPLATE APPLICATORS
1
Cleared 510(K)
K
90
4933
VARIOUS AFTERLOADING APPLICATORS
1
Cleared 510(K)
K
90
3403
CT-COMPATIBLE FLETCHER SYSTEM APPLICATOR
1
Cleared 510(K)
K
90
1842
PLASTIC-GUIDES
1
Cleared 510(K)
K
89
3703
AFTER LOADING DEVICE KIT
1
Cleared 510(K)
K
89
1377
HILARIS-NORI CERVIX APPLICATOR
1
Cleared 510(K)
K
89
0485
WANG FRONT LOADING APPLICATOR
1
Cleared 510(K)
K
89
0341
MICK 200-TP AND MICK TP NEEDLE
1
Cleared 510(K)
K
89
0191
HANDLING & CUTTING DEVICE FOR IRIDIUM-192 WIRE PIN
1
Cleared 510(K)
K
87
1216
HILARIS-NORI ENDOMETRIAL APPLICATOR
1
Cleared 510(K)
K
87
1217
HENSCHKE AFTERLOADING APPLICATOR
1
Cleared 510(K)
K
87
1213
KUMAR CERVICAL APPLICATOR
1
Cleared 510(K)
K
85
0571
I-125 IMPLANT GUN
1
Cleared 510(K)
K
83
2738
HEYER-SCHULTE AFTERLOADING CATHETER
1
Cleared 510(K)
K
81
3230
AFTERLOADING GYNECOLOGICAL APPLICATOR
1
Cleared 510(K)
K
80
1983
SCOTT NEEDLE & SCOTT MICK IMPLANTER
1
Cleared 510(K)
K
80
0320
CESIUM-137 AFTERLOADING SYSTEM /GYN.BRA.
1
Cleared 510(K)
IWK
Cyclotron, Medical
2
Product Code
IWL
System, Radiation Therapy, Neutron, Medical
2
Product Code
IWM
Synchrotron, Medical
2
Product Code
IXI
Block, Beam-Shaping, Radiation Therapy
2
Product Code
IYC
Generator, Orthovoltage, Therapeutic X-Ray
2
Product Code
IYD
Generator, Low Voltage, Therapeutic X-Ray
2
Product Code
IYE
Accelerator, Linear, Medical
2
Product Code
IYG
Betatron, Medical
2
Product Code
IYH
Generator, Dermatological (Grenz Ray), Therapeutic X-Ray
2
Product Code
IYI
Collimator, Orthovoltage, Therapeutic X-Ray
2
Product Code
IYJ
Collimator, Low Voltage, Therapeutic X-Ray
2
Product Code
IYK
Collimator, High Voltage, Therapeutic X-Ray
2
Product Code
IYL
Collimator, Dermatological, Therapeutic X-Ray
2
Product Code
JAD
System, Therapeutic, X-Ray
2
Product Code
JAE
Microtron, Medical
2
Product Code
JAI
Couch, Radiation Therapy, Powered
2
Product Code
JAQ
System, Applicator, Radionuclide, Remote-Controlled
2
Product Code
KPQ
System, Simulation, Radiation Therapy
2
Product Code
KPZ
Generator, High Voltage, X-Ray, Therapeutic
2
Product Code
KQA
Device, Beam Limiting, X-Ray, Therapeutic
2
Product Code
KXK
Source, Brachytherapy, Radionuclide
2
Product Code
LHN
System, Radiation Therapy, Charged-Particle, Medical
2
Product Code
MUJ
System, Planning, Radiation Therapy Treatment
2
Product Code
MWW
Accessory - Film Dosimetry System
2
Product Code
NMP
Needle, Isotope, Reprocessed
2
Product Code
NZT
Dosimeter, Ionizing Radiation, Implanted
2
Product Code
OIN
Prostate Seeding Kit
2
Product Code
ONL
Conformal Brachytherapy Source
2
Product Code
OVB
Hydrogel Spacer
2
Product Code
PCT
Prostate Immobilizer Rectal Balloon
2
Product Code
RGC
X-Ray Field Indicator Light (Laser)
1
Product Code
Subpart G—Miscellaneous Devices
CFR Sub-Part
General and Plastic Surgery
Review Panel
Toxicology
Review Panel
Medical Genetics
Review Panel
Unknown
Review Panel
Last synced on 23 May 2025 at 11:06 pm
RA
/
subpart-f—therapeutic-devices
/
IWJ
/
K924290
View Source
BEST INDUSTRIES CARTRIDGE & GUN
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K924290
510(k) Type
Traditional
Applicant
BEST INDUSTRIES
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
6/4/1993
Days to Decision
287 days
Submission Type
Statement
FDA Browser
by
Innolitics
Anesthesiology
Cardiovascular
Chemistry
Dental
Ear, Nose, Throat
Gastroenterology and Urology
General Hospital
Hematology
Immunology
Microbiology
Neurology
Obstetrical and Gynecological
Ophthalmic
Orthopedic
Pathology
Physical Medicine
Radiology
Miscellaneous
Subpart B—Diagnostic Devices
Subpart C—Obstetrical and Gynecological Monitoring Devices
Subpart F—Therapeutic Devices
FCD
Barium Enema Kit
ITZ
Assembly, Tube Housing, X-Ray, Therapeutic
IWA
Source, Wire, Iridium, Radioactive
IWB
System, Radiation Therapy, Radionuclide
IWD
Device, Beam Limiting, Teletherapy, Radionuclide
IWE
Monitor, Patient Position, Light-Beam
IWF
Needle, Isotope, Gold, Titanium, Platinum
IWG
Seed, Isotope, Gold, Titanium, Platinum
IWH
Source, Teletherapy, Radionuclide
IWI
Source, Isotope, Sealed, Gold, Titanium, Platinum
IWJ
System, Applicator, Radionuclide, Manual
K
01
0166
IMAGYN ISOSLEEVE / ISOSTAR NEEDLE SYSTEM
K
98
0997
PGK DEVICE (MODIFIED)
K
97
2554
REGANES RADIONUCLIDE SEED MAGAZINE
K
97
3037
N.I.T., INC. RADIONUCLIDE SEED APPLICATOR, MODEL SA-1000
K
97
4118
WORLDWIDE MEDICAL TECHNOLOGIES SEED IMPLANT NEEDLE SET
K
97
3786
NORTHWEST RADIATION THERAPY PRODUCTS, PRECISION STEPPER AND GUIDE
K
97
3638
N.I.T., INC. NEEDLE GUIDING TEMPLATE
K
97
3184
PROSTATE SEEDING NEEDLE
K
96
3743
MANAN PROSTATE UNI-LOCK
K
95
1052
WEEKS APPLICATOR
K
96
1377
MANAN PROSTATE LOCKING INTRODUCER SET
K
94
4522
MORGANSTERN PROSTATE STABILIZATION AND SEEDING KIT
K
94
0121
IMPLANTERS/ADJUSTABLE/ANDERSON'S MARKERS
K
93
3410
IMPLANT APPLICATORS, CARTRIDGES/MAGAZINES, IMPLANTERS FOR PERMANENT IMPLANT OF RADIOACTIVE SEEDS/SOURCES
K
94
0550
COOK BRACH NEEDLE/RADIO DELIV CATH/FLEXI FLEXICATH
K
92
4290
BEST INDUSTRIES CARTRIDGE & GUN
K
91
3293
QUICK SEEDER
K
92
1886
NEEDLE TECHNOLOGIES SEED IMPLANT NEEDLE
K
92
1961
SDMO APPLICATOR CODE: ASN.8236
K
91
0862
VARIOUS TEMPLATE APPLICATORS
K
90
4933
VARIOUS AFTERLOADING APPLICATORS
K
90
3403
CT-COMPATIBLE FLETCHER SYSTEM APPLICATOR
K
90
1842
PLASTIC-GUIDES
K
89
3703
AFTER LOADING DEVICE KIT
K
89
1377
HILARIS-NORI CERVIX APPLICATOR
K
89
0485
WANG FRONT LOADING APPLICATOR
K
89
0341
MICK 200-TP AND MICK TP NEEDLE
K
89
0191
HANDLING & CUTTING DEVICE FOR IRIDIUM-192 WIRE PIN
K
87
1216
HILARIS-NORI ENDOMETRIAL APPLICATOR
K
87
1217
HENSCHKE AFTERLOADING APPLICATOR
K
87
1213
KUMAR CERVICAL APPLICATOR
K
85
0571
I-125 IMPLANT GUN
K
83
2738
HEYER-SCHULTE AFTERLOADING CATHETER
K
81
3230
AFTERLOADING GYNECOLOGICAL APPLICATOR
K
80
1983
SCOTT NEEDLE & SCOTT MICK IMPLANTER
K
80
0320
CESIUM-137 AFTERLOADING SYSTEM /GYN.BRA.
IWK
Cyclotron, Medical
IWL
System, Radiation Therapy, Neutron, Medical
IWM
Synchrotron, Medical
IXI
Block, Beam-Shaping, Radiation Therapy
IYC
Generator, Orthovoltage, Therapeutic X-Ray
IYD
Generator, Low Voltage, Therapeutic X-Ray
IYE
Accelerator, Linear, Medical
IYG
Betatron, Medical
IYH
Generator, Dermatological (Grenz Ray), Therapeutic X-Ray
IYI
Collimator, Orthovoltage, Therapeutic X-Ray
IYJ
Collimator, Low Voltage, Therapeutic X-Ray
IYK
Collimator, High Voltage, Therapeutic X-Ray
IYL
Collimator, Dermatological, Therapeutic X-Ray
JAD
System, Therapeutic, X-Ray
JAE
Microtron, Medical
JAI
Couch, Radiation Therapy, Powered
JAQ
System, Applicator, Radionuclide, Remote-Controlled
KPQ
System, Simulation, Radiation Therapy
KPZ
Generator, High Voltage, X-Ray, Therapeutic
KQA
Device, Beam Limiting, X-Ray, Therapeutic
KXK
Source, Brachytherapy, Radionuclide
LHN
System, Radiation Therapy, Charged-Particle, Medical
MUJ
System, Planning, Radiation Therapy Treatment
MWW
Accessory - Film Dosimetry System
NMP
Needle, Isotope, Reprocessed
NZT
Dosimeter, Ionizing Radiation, Implanted
OIN
Prostate Seeding Kit
ONL
Conformal Brachytherapy Source
OVB
Hydrogel Spacer
PCT
Prostate Immobilizer Rectal Balloon
RGC
X-Ray Field Indicator Light (Laser)
Subpart G—Miscellaneous Devices
General and Plastic Surgery
Toxicology
Medical Genetics
Unknown
RA
/
subpart-f—therapeutic-devices
/
IWJ
/
K924290
View Source
BEST INDUSTRIES CARTRIDGE & GUN
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K924290
510(k) Type
Traditional
Applicant
BEST INDUSTRIES
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
6/4/1993
Days to Decision
287 days
Submission Type
Statement