510k
Database
Specialties
Anesthesiology
531
Cardiovascular
1642
Chemistry
359
Dental
1314
Ear, Nose, Throat
242
Gastroenterology & Urology
954
General & Plastic Surgery
2166
General Hospital
2031
Hematology
126
Immunology
97
Medical Genetics
8
Microbiology
462
Neurology
951
Obstetrics & Gynecology
433
Ophthalmic
274
Orthopedic
2819
Pathology
52
Physical Medicine
515
Radiology
2400
Toxicology
155
Categories
LZA
Polymer Patient Examination Glove
407
LLZ
System, Image Processing,...
379
FXX
Mask, Surgical
357
GEX
Powered Laser Surgical Instrument
351
GEI
Electrosurgical, Cutting &...
299
IYN
System, Imaging, Pulsed Doppler,...
283
QIH
Automated Radiological Image...
275
HRS
Plate, Fixation, Bone
269
OLO
Orthopedic Stereotaxic Instrument
226
MAX
Intervertebral Fusion Device...
208
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Incutech, Inc.
Medical Device Manufacturer
·
US , Greensboro , NC
Incutech, Inc. - FDA 510(k) Cleared Devices
5 submissions
·
4 cleared
·
Since 1994
5
Total
4
Cleared
0
Denied
FDA 510(k) Regulatory Record - Incutech, Inc.
General Hospital
✕
3
devices
1-3 of 3
Filters
Cleared
Jan 27, 1995
SAFE VENT SYSTEM
K942394
·
FMF
General Hospital
·
253d
Cleared
Jul 22, 1994
EMPTY, SOLUTION TRANSFER CONTAINER WITH DETATCHABLE LEG SET
K941731
·
KPE
General Hospital
·
106d
Cleared
Mar 28, 1994
SOLUTION TRANSFER CONTAINER W/ATTACHED LEG SET (EMPTY)
K940258
·
KPE
General Hospital
·
66d
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5
General Hospital
3
Anesthesiology
2