510k
Database
Specialties
Anesthesiology
522
Cardiovascular
1610
Chemistry
356
Dental
1304
Ear, Nose, Throat
235
Gastroenterology & Urology
927
General & Plastic Surgery
2131
General Hospital
1978
Hematology
126
Immunology
91
Medical Genetics
8
Microbiology
449
Neurology
940
Obstetrics & Gynecology
426
Ophthalmic
271
Orthopedic
2697
Pathology
52
Physical Medicine
514
Radiology
2319
Toxicology
155
Categories
LZA
Polymer Patient Examination Glove
403
LLZ
System, Image Processing,...
367
GEX
Powered Laser Surgical Instrument
350
FXX
Mask, Surgical
347
GEI
Electrosurgical, Cutting &...
294
QIH
Automated Radiological Image...
273
IYN
System, Imaging, Pulsed Doppler,...
264
HRS
Plate, Fixation, Bone
262
OLO
Orthopedic Stereotaxic Instrument
218
NHA
Abutment, Implant, Dental,...
205
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Scivita Medical Technology Co., Ltd.
Medical Device Manufacturer
·
CN , Suzhou
Scivita Medical Technology Co., Ltd. - FDA 510(k) Cleared Devices
12 submissions
·
12 cleared
·
Since 2019
12
Total
12
Cleared
0
Denied
FDA 510(k) Regulatory Record - Scivita Medical Technology Co., Ltd.
General & Plastic Surgery
✕
2
devices
1-2 of 2
Filters
Cleared
Jan 13, 2023
Scivita 4KINSIGHT ICG Imaging System
K221252
·
GCJ
General & Plastic Surgery
·
256d
Cleared
Feb 24, 2021
4K UHD Laparoscope
K203255
·
GCJ
General & Plastic Surgery
·
112d
Filters
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12
Ear, Nose, Throat
4
Obstetrics & Gynecology
3
Gastroenterology & Urology
3
General & Plastic Surgery
2