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Subpart B—Diagnostic Devices
CFR Sub-Part
HRX
Arthroscope
2
Product Code
K
24
2417
VECTR – Video Endoscopic Carpal Tunnel Release System
2
Cleared 510(K)
K
24
3020
MIDASVu
2
Cleared 510(K)
K
23
3800
Vertos mild Device Kit (MDK-0002)
2
Cleared 510(K)
K
24
0535
Digital ClarusScope System; Digital NeuroPEN System
2
Cleared 510(K)
K
23
3675
FMS VUE™ Fluid Management and Tissue Debridement System
2
Cleared 510(K)
K
23
3115
Hawkeye Control Unit with Eyas Endoscope
2
Cleared 510(K)
K
22
3709
Kyphoplasty Balloon Catheter
2
Cleared 510(K)
K
22
1142
Kyphoplasty Balloon System
2
Cleared 510(K)
K
22
1919
DOUBLEFLO INFLOW/OUTFLOW PUMP, accessories and tubing sets
2
Cleared 510(K)
K
22
3406
SmartRelease Endoscopic Soft Tissue Release System
2
Cleared 510(K)
Show All 669 Submissions
LZE
Isometer
1
Product Code
NBH
Accessories, Arthroscopic
1
Product Code
NGR
Tester, Stiffness, Cartilage, Arthroscopic
2
Product Code
PPR
Surgical Cannulaes & Depth Gauge Kit For Arthroscopic Procedures
2
Product Code
QGQ
Bone Indentation Device
2
Product Code
Subpart D—Prosthetic Devices
CFR Sub-Part
Subpart E—Neurological Surgical Devices
CFR Sub-Part
Subpart E—Surgical Devices
CFR Sub-Part
Pathology
Review Panel
Physical Medicine
Review Panel
Radiology
Review Panel
General and Plastic Surgery
Review Panel
Toxicology
Review Panel
Medical Genetics
Review Panel
Unknown
Review Panel
Last synced on 18 April 2025 at 11:05 pm
OR
/
subpart-b—diagnostic-devices
/
HRX
/
K233800
View Source
Vertos mild Device Kit (MDK-0002)
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K233800
510(k) Type
Traditional
Applicant
Vertos Medical Inc
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
5/6/2024
Days to Decision
159 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
Miscellaneous
Subpart B—Diagnostic Devices
HRX
Arthroscope
K
24
2417
VECTR – Video Endoscopic Carpal Tunnel Release System
K
24
3020
MIDASVu
K
23
3800
Vertos mild Device Kit (MDK-0002)
K
24
0535
Digital ClarusScope System; Digital NeuroPEN System
K
23
3675
FMS VUE™ Fluid Management and Tissue Debridement System
K
23
3115
Hawkeye Control Unit with Eyas Endoscope
K
22
3709
Kyphoplasty Balloon Catheter
K
22
1142
Kyphoplasty Balloon System
K
22
1919
DOUBLEFLO INFLOW/OUTFLOW PUMP, accessories and tubing sets
K
22
3406
SmartRelease Endoscopic Soft Tissue Release System
Show All 669 Submissions
LZE
Isometer
NBH
Accessories, Arthroscopic
NGR
Tester, Stiffness, Cartilage, Arthroscopic
PPR
Surgical Cannulaes & Depth Gauge Kit For Arthroscopic Procedures
QGQ
Bone Indentation Device
Subpart D—Prosthetic Devices
Subpart E—Neurological Surgical Devices
Subpart E—Surgical Devices
Pathology
Physical Medicine
Radiology
General and Plastic Surgery
Toxicology
Medical Genetics
Unknown
OR
/
subpart-b—diagnostic-devices
/
HRX
/
K233800
View Source
Vertos mild Device Kit (MDK-0002)
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K233800
510(k) Type
Traditional
Applicant
Vertos Medical Inc
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
5/6/2024
Days to Decision
159 days
Submission Type
Summary