510k
Database
Specialties
Anesthesiology
534
Cardiovascular
1644
Chemistry
359
Dental
1323
Ear, Nose, Throat
243
Gastroenterology & Urology
956
General & Plastic Surgery
2174
General Hospital
2037
Hematology
126
Immunology
97
Medical Genetics
8
Microbiology
462
Neurology
952
Obstetrics & Gynecology
433
Ophthalmic
274
Orthopedic
2828
Pathology
52
Physical Medicine
515
Radiology
2403
Toxicology
155
Categories
LZA
Polymer Patient Examination Glove
407
LLZ
System, Image Processing,...
381
FXX
Mask, Surgical
358
GEX
Powered Laser Surgical Instrument
351
GEI
Electrosurgical, Cutting &...
301
IYN
System, Imaging, Pulsed Doppler,...
284
QIH
Automated Radiological Image...
275
HRS
Plate, Fixation, Bone
269
OLO
Orthopedic Stereotaxic Instrument
226
MAX
Intervertebral Fusion Device...
209
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Spiway, LLC
Medical Device Manufacturer
·
US , Laguna Beach , CA
Spiway, LLC - FDA 510(k) Cleared Devices
4 submissions
·
4 cleared
·
Since 2014
4
Total
4
Cleared
0
Denied
FDA 510(k) Regulatory Record - Spiway, LLC
Ear, Nose, Throat
✕
4
devices
1-4 of 4
Filters
Cleared
Oct 27, 2021
SPIWay Endonasal Access Guide
K213153
·
LYA
Ear, Nose, Throat
·
29d
Cleared
Feb 16, 2018
SPIWay Endonasal Access Guide
K180141
·
LYA
Ear, Nose, Throat
·
29d
Cleared
Jan 28, 2016
SPIWay Endonasal Access Guide
K153686
·
LYA
Ear, Nose, Throat
·
36d
Cleared
Jan 29, 2014
SPIWAY ENDONASAL ACCESS GUIDE
K132721
·
LYA
Ear, Nose, Throat
·
152d
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4
Ear, Nose, Throat
4