510k
Database
Specialties
Anesthesiology
542
Cardiovascular
1683
Chemistry
370
Dental
1341
Ear, Nose, Throat
250
Gastroenterology & Urology
979
General & Plastic Surgery
2201
General Hospital
2052
Hematology
126
Immunology
99
Medical Genetics
8
Microbiology
472
Neurology
969
Obstetrics & Gynecology
436
Ophthalmic
279
Orthopedic
2961
Pathology
52
Physical Medicine
515
Radiology
2457
Toxicology
155
Categories
LZA
Polymer Patient Examination Glove
409
LLZ
System, Image Processing,...
391
FXX
Mask, Surgical
358
GEX
Powered Laser Surgical Instrument
356
GEI
Electrosurgical, Cutting &...
307
IYN
System, Imaging, Pulsed Doppler,...
299
HRS
Plate, Fixation, Bone
281
QIH
Automated Radiological Image...
276
OLO
Orthopedic Stereotaxic Instrument
231
MAX
Intervertebral Fusion Device...
221
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Standard Bariatrics
Medical Device Manufacturer
·
US , Cincinnati , OH
Standard Bariatrics - FDA 510(k) Cleared Devices
10 submissions
·
10 cleared
·
Since 2016
10
Total
10
Cleared
0
Denied
FDA 510(k) Regulatory Record - Standard Bariatrics
Gastroenterology & Urology
✕
3
devices
1-3 of 3
Filters
Cleared
Sep 23, 2021
Standard Bougie, 38 Fr. and Hand Pump
K212728
·
KNT
Gastroenterology & Urology
·
27d
Cleared
Jun 29, 2021
Standard Bougie, 38 Fr.
K210437
·
KNT
Gastroenterology & Urology
·
137d
Cleared
Apr 08, 2020
Standard Bougie
K191885
·
KNT
Gastroenterology & Urology
·
268d
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10
General & Plastic Surgery
7
Gastroenterology & Urology
3