510k
Database
Specialties
Anesthesiology
8631
Cardiovascular
17669
Chemistry
12848
Dental
12298
Ear, Nose, Throat
3688
Gastroenterology & Urology
9664
General & Plastic Surgery
17902
General Hospital
17326
Hematology
3159
Immunology
3662
Medical Genetics
20
Microbiology
6898
Neurology
6181
Obstetrics & Gynecology
4413
Ophthalmic
4927
Orthopedic
17951
Pathology
1066
Physical Medicine
5198
Radiology
15414
Toxicology
2964
Categories
Powered Laser Surgical Instrument
GEX
2884
System, Image Processing, Radiological
LLZ
2293
Electrosurgical, Cutting &...
GEI
2293
Latex Patient Examination Glove
LYY
1954
Implant, Endosseous, Root-form
DZE
1538
Laparoscope, General & Plastic Surgery
GCJ
1432
Plate, Fixation, Bone
HRS
1332
Hearing Aid, Air-conduction,...
ESD
1302
System, Imaging, Pulsed Doppler,...
IYN
1185
Polymer Patient Examination Glove
LZA
1182
Browse all 339 categories →
Manufacturers
Search
Reports
Glossary
About
Search FDA 510(k) devices
510k Database
Manufacturers
KR
Bistool
Share
Medical Device Manufacturer
·
KR , Seoul
Bistool - FDA 510(k) Cleared Devices
1 submissions
·
1 cleared
·
Since 2018
Recent clearances:
SOFTXIL
View 1 510(k) Devices ↓
1
Total
1
Cleared
0
Denied
FDA 510(k) Regulatory Record - Bistool
General & Plastic Surgery
✕
1
devices
1-1 of 1
Filters
Cleared
Mar 16, 2018
SOFTXIL
K171851
·
MIB
General & Plastic Surgery
·
268d
Filters
Filter by Specialty
All
1
General & Plastic Surgery
1