PCU

Pancreatic Stent, Covered, Metallic, Removable

Product code
PCU
Device name
Pancreatic Stent, Covered, Metallic, Removable
Device class
Class 2
21 CFR
21 CFR 876.5015
Medical specialty
Gastroenterology, Urology
Marketing pathway
510(K)
Flag
Implant
510(k) clearances (last 3 years)
1
Summaries archived here
1 (direct download)
510(k) clearances (all years, FDA)
11 (all years; only the last 3 years are listed here)

FDA classification definition

To facilitate transmural endoscopic drainage of pancreatic pseudocysts

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

510(k) clearances, last 3 years (1)

Last three years. Most recent: 2026-03-13.

NumberDecision dateApplicantDevice nameSummary
K2526482026-03-13Taewoong Medical Co., Ltd.Niti-S SPAXUS StentPDF

1 summaries are archived here for direct download.

Official FDA classification page: PCU
Classification and pathway per current FDA publications. Data from openFDA (CC0).