QNE

Endoscopic Pancreatic Debridement Device

Product code: QNE
Device name: Endoscopic Pancreatic Debridement Device
Device class: Class 2
21 CFR: 21 CFR 876.4330
Medical specialty: Gastroenterology, Urology
Marketing pathway: 510(K)
510(k) clearances (all years, FDA): 1 (all years; only the last 3 years are listed here)

FDA classification 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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

Official FDA classification page: QNE

Classification and pathway per current FDA publications. Data from openFDA (CC0).