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Miscellaneous
Miscellaneous
Subpart B—Diagnostic Devices
CFR Sub-Part
HRX
Arthroscope
2
Product Code
K
25
3217
MiiS Horus Arthroscope (EJA 100); MiiS Horus Endoscope Display System -Tablet (EDS 500); MiiS Horus Endoscope Display System -Video Box (EVS 700)
2
Cleared 510(K)
K
25
0795
PUREVUE™ FMS
2
Cleared 510(K)
K
25
2666
Articulator Arthroscopic Bur
2
Cleared 510(K)
K
25
2458
Kyphoplasty Balloon Dilatation Catheters
2
Cleared 510(K)
K
25
2594
UltraGuideCTR® image guided soft tissue release system
2
Cleared 510(K)
K
24
3774
ELID (Endoscopic Less Invasive Decompression) System
2
Cleared 510(K)
K
24
1990
SpineSite Endoscope System
2
Cleared 510(K)
K
24
3602
Arthrex Spine Endoscope
2
Cleared 510(K)
K
24
2417
VECTR – Video Endoscopic Carpal Tunnel Release System
2
Cleared 510(K)
K
24
3020
MIDASVu
2
Cleared 510(K)
Show All 677 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 25 January 2026 at 3:41 am
OR
/
subpart-b—diagnostic-devices
/
HRX
/
K253217
View Source
MiiS Horus Arthroscope (EJA 100); MiiS Horus Endoscope Display System -Tablet (EDS 500); MiiS Horus Endoscope Display System -Video Box (EVS 700)
Page Type
Cleared 510(K)
PDF
PDF
* The FDA doesn't provide PDFs for all submissions.
PDF
Analyzed PDF
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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
25
3217
MiiS Horus Arthroscope (EJA 100); MiiS Horus Endoscope Display System -Tablet (EDS 500); MiiS Horus Endoscope Display System -Video Box (EVS 700)
K
25
0795
PUREVUE™ FMS
K
25
2666
Articulator Arthroscopic Bur
K
25
2458
Kyphoplasty Balloon Dilatation Catheters
K
25
2594
UltraGuideCTR® image guided soft tissue release system
K
24
3774
ELID (Endoscopic Less Invasive Decompression) System
K
24
1990
SpineSite Endoscope System
K
24
3602
Arthrex Spine Endoscope
K
24
2417
VECTR – Video Endoscopic Carpal Tunnel Release System
K
24
3020
MIDASVu
Show All 677 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
/
K253217
View Source
MiiS Horus Arthroscope (EJA 100); MiiS Horus Endoscope Display System -Tablet (EDS 500); MiiS Horus Endoscope Display System -Video Box (EVS 700)
Page Type
Cleared 510(K)
PDF
PDF
* The FDA doesn't provide PDFs for all submissions.
PDF
Analyzed PDF
Loading...