|
Device |
endoscopic irrigation/suction system |
Regulation Description |
Endoscope and accessories. |
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
|
1
|
FINEMEDIX CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
GA HEALTH COMPANY LIMITED |
|
SUBSTANTIALLY EQUIVALENT
|
6
|
1. K200388 Vacutore Air/Water Bottle Tubing, Vacutore CO2 Tub ...
|
2. K200479 AquaPulse Auxiliary Water Connector
|
3. K202560 AquaPulse Irrigation Tubing
|
4. K223171 AquaPulse® Irrigation Tubing
|
5. K230932 ANDORATE® Valve Kit
|
6. K231602 Protego Air Water Connector; Protego Air Water Bot ...
|
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
|
SANESO, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
YANGZHOU FARTLEY MEDICAL INSTRUMENT TECHNOLOGY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ZHEJIANG CHUANGXIANG MEDICAL TECHNOLOGY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
|
|
|
|