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
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
K
22
2972
BioProtect Balloon Implant™ System
2
Cleared 510(K)
K
22
0641
Barrigel Injectable Gel
2
Cleared 510(K)
K
20
2224
SpaceOAR System
2
Cleared 510(K)
K
18
2971
SpaceOAR Vue Hydrogel
2
Cleared 510(K)
K
18
1465
SpaceOAR System
2
Cleared 510(K)
DEN
14
0030
SpaceOAR System
2
Cleared 510(K)
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 16 August 2024 at 11:05 pm
RA
/
subpart-f—therapeutic-devices
/
OVB
/
K202224
View Source
SpaceOAR System
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K202224
510(k) Type
Special
Applicant
Boston Scientific Corporation
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
8/28/2020
Days to Decision
21 days
Submission Type
Summary
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
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
K
22
2972
BioProtect Balloon Implant™ System
K
22
0641
Barrigel Injectable Gel
K
20
2224
SpaceOAR System
K
18
2971
SpaceOAR Vue Hydrogel
K
18
1465
SpaceOAR System
DEN
14
0030
SpaceOAR System
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
/
OVB
/
K202224
View Source
SpaceOAR System
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K202224
510(k) Type
Special
Applicant
Boston Scientific Corporation
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
8/28/2020
Days to Decision
21 days
Submission Type
Summary