Product code QNE

Device name

Endoscopic Pancreatic Debridement Device

Medical specialty

Gastroenterology, Urology

Device class

2

Regulation number

876.4330

Review panel

GU

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Ineligible

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.

Source

FDA openFDA device classification dataset