Device Classification Name |
electrosurgical, cutting & coagulation & accessories
|
510(k) Number |
K192265 |
Device Name |
gi-4000 Electrosurgical Generator |
Applicant |
United States Endoscopy Group, Inc |
5976 Heisley Road |
Mentor,
OH
44060
|
|
Applicant Contact |
Carroll L. Martin |
Correspondent |
United States Endoscopy Group, Inc |
5976 Heisley Road |
Mentor,
OH
44060
|
|
Correspondent Contact |
Carroll L. Martin |
Regulation Number | 878.4400
|
Classification Product Code |
|
Date Received | 08/21/2019 |
Decision Date | 05/21/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|