Product code PCU

Device name

Pancreatic Stent, Covered, Metallic, Removable

Medical specialty

Gastroenterology, Urology

Device class

2

Regulation number

876.5015

Review panel

GU

Implant

Y

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Eligible

Definition

To facilitate transmural endoscopic drainage of pancreatic pseudocysts

Source

FDA openFDA device classification dataset