510k
Database
Specialties
Anesthesiology
481
Cardiovascular
1458
Chemistry
338
Dental
1156
Ear, Nose, Throat
215
Gastroenterology & Urology
848
General & Plastic Surgery
1910
General Hospital
1451
Hematology
125
Immunology
90
Medical Genetics
8
Microbiology
428
Neurology
823
Obstetrics & Gynecology
364
Ophthalmic
239
Orthopedic
2510
Pathology
49
Physical Medicine
442
Radiology
2077
Toxicology
147
Categories
GEX
Powered Laser Surgical Instrument
311
LLZ
System, Image Processing,...
306
LZA
Polymer Patient Examination Glove
281
GEI
Electrosurgical, Cutting &...
263
QIH
Automated Radiological Image...
257
IYN
System, Imaging, Pulsed Doppler,...
247
HRS
Plate, Fixation, Bone
247
OLO
Orthopedic Stereotaxic Instrument
206
NHA
Abutment, Implant, Dental,...
197
MAX
Intervertebral Fusion Device...
174
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Optus, Inc.
Medical Device Manufacturer
·
US , Denver , CO
Optus, Inc. - FDA 510(k) Cleared Devices
10 submissions
·
10 cleared
·
Since 1994
10
Total
10
Cleared
0
Denied
FDA 510(k) Regulatory Record - Optus, Inc.
Gastroenterology & Urology
✕
1
devices
1-1 of 1
Filters
Cleared
May 26, 1995
OPTUS CYSTOSCOPES AND PEDIATRIC CYSTOSCOPES
K945262
·
FAJ
Gastroenterology & Urology
·
210d
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All
10
Ear, Nose, Throat
3
Orthopedic
2
General & Plastic Surgery
2
Obstetrics & Gynecology
1
Gastroenterology & Urology
1
Anesthesiology
1