510k
Database
Specialties
Anesthesiology
542
Cardiovascular
1680
Chemistry
365
Dental
1338
Ear, Nose, Throat
249
Gastroenterology & Urology
973
General & Plastic Surgery
2194
General Hospital
2047
Hematology
126
Immunology
99
Medical Genetics
8
Microbiology
469
Neurology
965
Obstetrics & Gynecology
433
Ophthalmic
279
Orthopedic
2934
Pathology
52
Physical Medicine
515
Radiology
2444
Toxicology
155
Categories
LZA
Polymer Patient Examination Glove
409
LLZ
System, Image Processing,...
388
FXX
Mask, Surgical
358
GEX
Powered Laser Surgical Instrument
356
GEI
Electrosurgical, Cutting &...
305
IYN
System, Imaging, Pulsed Doppler,...
299
QIH
Automated Radiological Image...
276
HRS
Plate, Fixation, Bone
275
OLO
Orthopedic Stereotaxic Instrument
227
MAX
Intervertebral Fusion Device...
220
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Gesco Intl., Inc.
Medical Device Manufacturer
·
US , Walker , MI
Gesco Intl., Inc. - FDA 510(k) Cleared Devices
26 submissions
·
22 cleared
·
Since 1978
26
Total
22
Cleared
0
Denied
FDA 510(k) Regulatory Record - Gesco Intl., Inc.
Anesthesiology
✕
3
devices
1-3 of 3
Filters
Cleared
Mar 16, 1993
PALA-NATE
K923591
·
BTR
Anesthesiology
·
239d
Cleared
Jul 24, 1991
SPINAL TAP NEEDLE
K910652
·
BSP
Anesthesiology
·
160d
Cleared
May 22, 1987
GESCO ASPIRATOR
K870962
·
BSY
Anesthesiology
·
73d
Filters
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All
26
General Hospital
12
Gastroenterology & Urology
4
General & Plastic Surgery
3
Anesthesiology
3
Cardiovascular
2
Obstetrics & Gynecology
1
Neurology
1