|
Device |
unit, electrosurgical, endoscopic (with or without accessories) |
Regulation Description |
Endoscopic electrosurgical unit and accessories. |
Product Code | KNS |
Regulation Number |
876.4300
|
Device Class |
2
|
Premarket Reviews |
Manufacturer | Decision |
ANREI MEDICAL (HANGZHOU) CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
AQUA MEDICAL, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
BEIJING ZKSK TECHNOLOGY CO.,LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BOSTON SCIENTIFIC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BOSTON SCIENTIFIC CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
CREO MEDICAL LTD |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
CREO MEDICAL LTD. |
|
SUBSTANTIALLY EQUIVALENT - KIT
|
1
|
G-FLEX EUROPE SPRL |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
HANGZHOU AGS MEDTECH CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
JIANGSU VEDKANG MEDICAL SCIENCE AND TECHNOLOGY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
LAMIDEY NOURY MEDICAL |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MICRO-TECH (NANJING) CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
STARMED CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
TAEWOONG MEDICAL CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
WILSON-COOK MEDICAL INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
WILSON-COOK MEDICAL, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ZHEJIANG SOUDON MEDICAL TECHNOLOGY CO.,LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
|
|
|
|