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Innolitics
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Subpart B—Cardiovascular Diagnostic Devices
CFR Sub-Part
Subpart B—Diagnostic Devices
CFR Sub-Part
Subpart B—Neurological Diagnostic Devices
CFR Sub-Part
Subpart B—Physical Medicine Diagnostic Devices
CFR Sub-Part
Subpart C—Cardiovascular Monitoring Devices
CFR Sub-Part
Subpart D—Physical Medicine Prosthetic Devices
CFR Sub-Part
Subpart E—Neurological Surgical Devices
CFR Sub-Part
Subpart E—Surgical Devices
CFR Sub-Part
QQO
Cranial Measurement Software
1
Product Code
HST
Apparatus, Traction, Non-Powered
1
Product Code
ONO
Neurosurgical Laser With Mr Thermography
2
Product Code
K
24
0877
Monteris Medical NeuroBlate System
2
Cleared 510(K)
K
21
4125
TRANBERG Thermoguide Therapy System
2
Cleared 510(K)
K
21
1269
Visualase MRI-Guided Laser Ablation System (SW 3.4)
2
Cleared 510(K)
Subpart F—Cardiovascular Therapeutic Devices
CFR Sub-Part
Subpart F—Neurological Therapeutic Devices
CFR Sub-Part
Subpart F—Physical Medicine Therapeutic Devices
CFR Sub-Part
Subpart F—Therapeutic Devices
CFR Sub-Part
Obstetrical and Gynecological
Review Panel
Ophthalmic
Review Panel
Orthopedic
Review Panel
Pathology
Review Panel
Physical Medicine
Review Panel
Radiology
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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
NE
/
subpart-e—surgical-devices
/
ONO
/
K211269
View Source
Visualase MRI-Guided Laser Ablation System (SW 3.4)
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K211269
510(k) Type
Traditional
Applicant
Medtronic Navigation, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
1/7/2022
Days to Decision
255 days
Submission Type
Summary
FDA Browser
by
Innolitics
Anesthesiology
Cardiovascular
Chemistry
Dental
Ear, Nose, Throat
Gastroenterology and Urology
General Hospital
Hematology
Immunology
Microbiology
Neurology
Miscellaneous
Subpart B—Cardiovascular Diagnostic Devices
Subpart B—Diagnostic Devices
Subpart B—Neurological Diagnostic Devices
Subpart B—Physical Medicine Diagnostic Devices
Subpart C—Cardiovascular Monitoring Devices
Subpart D—Physical Medicine Prosthetic Devices
Subpart E—Neurological Surgical Devices
Subpart E—Surgical Devices
QQO
Cranial Measurement Software
HST
Apparatus, Traction, Non-Powered
ONO
Neurosurgical Laser With Mr Thermography
K
24
0877
Monteris Medical NeuroBlate System
K
21
4125
TRANBERG Thermoguide Therapy System
K
21
1269
Visualase MRI-Guided Laser Ablation System (SW 3.4)
Subpart F—Cardiovascular Therapeutic Devices
Subpart F—Neurological Therapeutic Devices
Subpart F—Physical Medicine Therapeutic Devices
Subpart F—Therapeutic Devices
Obstetrical and Gynecological
Ophthalmic
Orthopedic
Pathology
Physical Medicine
Radiology
General and Plastic Surgery
Toxicology
Medical Genetics
Unknown
NE
/
subpart-e—surgical-devices
/
ONO
/
K211269
View Source
Visualase MRI-Guided Laser Ablation System (SW 3.4)
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K211269
510(k) Type
Traditional
Applicant
Medtronic Navigation, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
1/7/2022
Days to Decision
255 days
Submission Type
Summary