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. |
Physical State |
may include: pump, motor, tubing, controller, air switch, power supply, transducer, digital display, suction attachment, bottle cap |
Technical Method |
Connects to tubing from pump and goes down working channel of endoscope |
Target Area |
endoscope |
Regulation Medical Specialty |
Gastroenterology/Urology |
Review Panel |
Gastroenterology/Urology |
Product Code | OCX |
Premarket Review |
Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices
(OHT3)
Renal, Gastrointestinal, Obesity and Transplant Devices
(DHT3A)
|
Submission Type |
510(k)
|
Regulation Number |
876.1500
|
Device Class |
2
|
Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
GMP Exempt? |
No
|
Summary Malfunction Reporting |
Eligible |
Implanted Device? |
No
|
Life-Sustain/Support Device? |
No
|
Recognized Consensus Standard
|
Third Party Review |
Not Third Party Eligible |
|
|