|
Device |
snare, flexible |
Product Code | FDI |
Regulation Number |
876.4300
|
Device Class |
2
|
Premarket Reviews |
Manufacturer | Decision |
BEIJING ZKSK TECHNOLOGY CO.,LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BOSTON SCIENTIFIC CORP. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
BOSTON SCIENTIFIC CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
CONMED ENDOSCOPIC TECHNOLOGIES, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
1. K091355 DEUCE POLYPECTOMY SNARE, MODELS 000995, 000996,000 ...
|
ENDOCHOICE, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
FINEMEDIX CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
HANGZHOU AGS MEDTECH CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
HANGZHOU AGS MEDTECH CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
INCORE CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
INTELLIGENT ENDOSCOPY |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
JIANGSU VEDKANG MEDICAL SCIENCE AND TECHNOLOGY CO.,LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MEDI-GLOBE CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MICRO- TECH (NANJING) CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
OLYMPUS MEDICAL SYSTEMS CORP. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
OVESCO ENDOSCOPY AG |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
STERIS CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
UNITED STATES ENDOSCOPY |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
UNITED STATES ENDOSCOPY GROUP, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
6
|
WILSON-COOK MEDICAL, INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
WILSON-COOK MEDICAL, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
YANGZHOU FARTLEY MEDICAL INSTRUMENT TECHNOLOGY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ZHEJIANG CHUANGXIANG MEDICAL TECHNOLOGY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
|
|
|
|