| Device |
endoscopic pancreatic debridement device |
| Definition |
An endoscopic pancreatic debridement device is inserted via an endoscope and placed through a cystogastrostomy fistula into the pancreatic cavity. It is intended for removal of necrotic tissue from a walled off pancreatic necrosis (WOPN) cavity. |
| Physical State |
A morcellator intended to resect and remove necrotic pancreatic tissue to be used via an endoscope. |
| Technical Method |
The device morcellates walled off pancreatic tissue by the use of a resecting catheter, console and collection device. The device has an inner and outer cutter and is connected to aspiration. The distal ends of the lavage and aspiration tubing are permanently affixed to the catheter. The collection device is a custom trap designed specifically to caputure specimens. |
| Target Area |
Pancreas |
| Regulation Medical Specialty |
Gastroenterology/Urology |
| Review Panel |
Gastroenterology/Urology |
|---|
| Product Code | QNE |
|---|
| 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 |
876.4330
|
|---|
| 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 |
