Device |
endoscopic central control unit |
Regulation Description |
Endoscope and accessories. |
Definition |
To control endoscopic and other ancillary surgical equipment in one central location, either by remote control, touch screen, or voice command. |
Physical State |
may include: monitor, remote (or other wireless device), microphone, card adaptor, cables, other hardware and software |
Technical Method |
Connect operating systems into central control unit |
Target Area |
endoscopic and other ancillary surgical equipment |
Regulation Medical Specialty |
Gastroenterology/Urology |
Review Panel |
Gastroenterology/Urology |
Product Code | ODA |
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
|
Third Party Review |
Not Third Party Eligible |
|
|