|
Device |
endoscopic irrigation/suction system |
Definition |
To supply sterile water, other solutions and/or suction to endoscopes during endoscopic procedures. |
Product Code | OCX |
Regulation Number |
876.1500
|
Device Class |
2
|
Premarket Reviews |
Manufacturer | Decision |
BIOTEX INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BIOTEX, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CHANGZHOU ENDOCLEAN MEDICAL DEVICE CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CHONGQING JINSHAN SCIENCE & TECHNOLOGY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CIPHER SURGICAL LIMITED |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
DIVERSATEK HEALTHCARE |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ERBE USA, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
FINEMEDIX CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
GA HEALTH COMPANY LIMITED |
|
SUBSTANTIALLY EQUIVALENT
|
6
|
HOBBS MEDICAL, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
KEYMED (MEDICAL AND INDUSTRIAL EQUIPMENT) LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MEDIVATORS |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
NISSHA MEDICAL TECHNOLOGIES SAS |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
OLYMPUS MEDICAL SYSTEMS CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PARTNERSHIP MEDICAL LIMITED |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
PENTAX MEDICAL, A DIVISION OF PENTAX OF AMERICA, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SANESO, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SMARTDATA SUZHOU CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
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
|
2
|
|
|
|
|