510k
Database
Specialties
Anesthesiology
527
Cardiovascular
1636
Chemistry
358
Dental
1304
Ear, Nose, Throat
239
Gastroenterology & Urology
947
General & Plastic Surgery
2157
General Hospital
2024
Hematology
126
Immunology
96
Medical Genetics
8
Microbiology
459
Neurology
949
Obstetrics & Gynecology
430
Ophthalmic
272
Orthopedic
2797
Pathology
52
Physical Medicine
515
Radiology
2372
Toxicology
155
Categories
LZA
Polymer Patient Examination Glove
407
LLZ
System, Image Processing,...
376
FXX
Mask, Surgical
357
GEX
Powered Laser Surgical Instrument
351
GEI
Electrosurgical, Cutting &...
297
IYN
System, Imaging, Pulsed Doppler,...
279
QIH
Automated Radiological Image...
275
HRS
Plate, Fixation, Bone
269
OLO
Orthopedic Stereotaxic Instrument
221
NHA
Abutment, Implant, Dental,...
205
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Gordian Surgical, Ltd.
Medical Device Manufacturer
·
IL , Karmiel
Gordian Surgical, Ltd. - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 2016
3
Total
3
Cleared
0
Denied
FDA 510(k) Regulatory Record - Gordian Surgical, Ltd.
General & Plastic Surgery
✕
3
devices
1-3 of 3
Filters
Cleared
Dec 16, 2025
TroClose 1200
K253620
·
GAM
General & Plastic Surgery
·
28d
Cleared
Jun 15, 2017
TroClose1200, TroClose1200 Cannula
K171494
·
GAM
General & Plastic Surgery
·
24d
Cleared
Nov 17, 2016
TroClose1200
K160564
·
GAM
General & Plastic Surgery
·
262d
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3
General & Plastic Surgery
3