Device |
endoscopic traction device |
Definition |
An endoscopic traction device is a prescription device that is endoscopically applied to retract tissue in the gastrointestinal tract during dissection procedures to increase visualization of the dissection plane and assist in tissue resection, exposure, and removal. |
Physical State |
Traction device and system accessories |
Technical Method |
Uses a traction device to grasp and retract tissue during endoscopic procedures |
Target Area |
Gastrointestinal tract |
Regulation Medical Specialty |
Gastroenterology/Urology |
Review Panel |
Gastroenterology/Urology |
Product Code | QSW |
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 |
876.4410
|
Device Class |
2
|
Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
GMP Exempt? |
No
|
Summary Malfunction Reporting |
Ineligible |
Implanted Device? |
No
|
Life-Sustain/Support Device? |
No
|
Third Party Review |
Not Third Party Eligible |
|
|