|
Device |
endoscopic injection needle, gastroenterology-urology |
Definition |
inserted through endoscope for injection of a solution, gas, or implantable materials into gi or gu tissue. |
Product Code | FBK |
Regulation Number |
876.1500
|
Device Class |
2
|
Premarket Reviews |
Manufacturer | Decision |
ALTON (SHANGHAI) MEDICAL INSTRUMENTS CO. LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ANREI MEDICAL (HANGZHOU) CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BEIJING ZKSK TECHNOLOGY CO.,LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BOSTON SCIENTIFIC CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BYRNE MEDICAL INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CARBON MEDICAL TECHNOLOGIES, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
COLOPLAST A/S |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
COOK INCORPORATED |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
COOK IRELAND LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ENDOCHOICE, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
FINEMEDIX CO. LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
G-FLEX EUROPE SPRL |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
HANGZHOU AGS MEDTECH CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
INCORE CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
JIANGSU VEDKANG MEDICAL SCIENCE AND TECHNOLOGY CO.,LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
LABORIE MEDICAL TECHNOLOGIES CORP. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
LABORIE MEDICAL TECHNOLOGIES, LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
LINA MEDICAL APS |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MICRO-TECH (NANJING) CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
NINGBO XINWELL MEDICAL TECHNOLOGY CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
OLYMPUS MEDICAL SYSTEMS CORP. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
STERIS |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
UNITED STATES ENDOSCOPY GROUP, INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
URO-1, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
UROPLASTY, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
WILSON INSTRUMENTS (SHANGHAI) COMPANY LIMITED |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
WILSON-COOK MEDICAL INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
WILSON-COOK MEDICAL, INC. / COOK ENDOSCOPY |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
YANGZHOU FARTLEY MEDICAL INSTRUMENT TECHNOLOGY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ZHEJIANG CHUANGXIANG MEDICAL TECHNOLOGY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ZHEJIANG SOUDON MEDICAL TECHNOLOGY CO.,LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
|
|
|
|