QNEClass II
Endoscopic Pancreatic Debridement Device
Gastroenterology, Urology · 21 CFR 876.4330
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.
MDR events1All time
Recalls0All time
Registered firms1Currently listed
510(k) clearances1All time
Recent MDR events
1 adverse event reports on file
Event type breakdown
Injury1
Most-reported manufacturers
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
1 firms currently registered for this product code
510(k) clearances
1 clearances for this product code