DeviceClearance

Product code QNE— Gastroenterology, Urology

EndoRotor Device

Classification name
Endoscopic Pancreatic Debridement Device
Device class
Class 2
Regulation
21 CFR 876.4330
Advisory panel
Gastroenterology, Urology
Total cleared
1
First cleared
Most recent

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.”

— U.S. Food and Drug Administration, device classification record for product code QNE under 21 CFR 876.4330, via openFDA

Market context for product code QNE

FDA has cleared 1 device under product code QNE, all in 2020, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Top applicants under product code QNE

Recent clearances under product code QNE

Data sourced from openFDA. This site is unofficial and independent of the FDA.