DeviceClearance

Product code PCU— Gastroenterology, Urology

AXIOS Stent and Electrocautery Enhanced Delivery System

Classification name
Pancreatic Stent, Covered, Metallic, Removable
Device class
Class 2
Regulation
21 CFR 876.5015
Advisory panel
Gastroenterology, Urology
Total cleared
11
First cleared
Most recent

FDA classification definition

“To facilitate transmural endoscopic drainage of pancreatic pseudocysts”

— U.S. Food and Drug Administration, device classification record for product code PCU under 21 CFR 876.5015, via openFDA

Market context for product code PCU

FDA has cleared 11 devices under product code PCU between 2013 and 2026, filed by 4 applicant companies. 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.

Clearances per year

Top applicants under product code PCU

Adverse events under product code PCU

product code PCU
Death
47
Injury
804
Malfunction
709
Total
1,560

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recent clearances under product code PCU

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