Device |
endoscopic electrosurgical clip cutting system |
Regulation Description |
Endoscopic electrosurgical clip cutting system. |
Definition |
To fragment metallic clips and remove them from the digestive tract. |
Physical State |
Generator supplies energy to clip cutter, whose tip is placed on the opposite edges of the metallic clip, and direct current is applied to fragment the clip. |
Technical Method |
Applies direct current across clip edges. |
Target Area |
Gastrointestinal tract, digestive tract. |
Regulation Medical Specialty |
Obstetrics/Gynecology |
Review Panel |
Gastroenterology/Urology |
Product Code | QAG |
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 |
876.4310
|
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 |