Device |
endoscopic morcellator gastroenterology |
Regulation Description |
Hysteroscope and accessories. |
Definition |
For use in endoscopic procedures by a trained gastroenterologist to resect and remove residual tissue from the peripheral margins following EMR (Endoscopic Mucosal Resection) |
Physical State |
Rotating, cutting cannula with aspiration of tissue |
Technical Method |
Mechanical removal of gastrointestinal tissue |
Target Area |
Gastrointestinal tract |
Regulation Medical Specialty |
Obstetrics/Gynecology |
Review Panel |
Gastroenterology/Urology |
Product Code | PTE |
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 |
884.1690
|
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 |