|
Device |
endoscopic access overtube, gastroenterology-urology |
Definition |
To facilitate passage and aid advancement of endoscopes into the body, especially in cases of repeated intubation. |
Product Code | FED |
Regulation Number |
876.1500
|
Device Class |
2
|
Premarket Reviews |
Manufacturer | Decision |
APOLLO ENDOSURGERY, INC. |
|
SE - WITH LIMITATIONS
|
1
|
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BARONOVA, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BAROSENSE, INC |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
BODDINGTONS PLASTICS LTD |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
BOSTON SCIENTIFIC |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
BOSTON SCIENTIFIC CORP. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
C.R. BARD, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
C2 THERAPEUTICS |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CALYXO, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
COLOPLAST A/S |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
COOK INCORPORATED |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
CROSPON, LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
DORNIER MEDTECH AMERICA INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ENDO-AID, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
FUJIFILM HEALTHCARE AMERICAS CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
FUJINON, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
H&A MUI ENTERPRISES INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
KALERA MEDICAL, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MEDIVATORS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MICRO-TECH (NANJING) CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
NEPTUNE MEDICAL, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
NOVADAQ TECHNOLOGIES, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SOFTSCOPE MEDICAL TECHNOLOGIES, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SUMITOMO BAKELITE CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SUZHOU BEYO MEDICAL TECHNOLOGY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
TROKAMED GMBH |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
UNITED STATES ENDOSCOPY GROUP, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
VISIONSENSE LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
WELL LEAD MEDICAL CO. LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
WELL LEAD MEDICAL CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
YOUCARE TECHNOLOGY CO., LTD. (WUHAN) |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ZHEJIANG CHUANGXIANG MEDICAL TECHNOLOGY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
|
|
|
|