Device |
endoscopic video imaging system/component, gastroenterology-urology |
Regulation Description |
Endoscope and accessories. |
Definition |
To allow for visualization of body cavities through an endoscope by projecting images to a monitor. |
Physical State |
May include: ccd camera, monitor, other software or hardware associated with video equipment, and components from other regulations, such as a pump. |
Technical Method |
Inserted through endoscope |
Target Area |
various body cavities, hollow organs, and canals in GI and GU tract |
Regulation Medical Specialty |
Gastroenterology/Urology |
Review Panel |
Gastroenterology/Urology |
Product Code | OCS |
Premarket Review |
Renal, Gastrointestinal, Obesity and Transplant Devices
(DHT3A)
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 Standards
|
Third Party Review |
Not Third Party Eligible |