PCU
- 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
510(k) clearances, last 3 years (1)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K252648 | 2026-03-13 | Taewoong Medical Co., Ltd. | Niti-S SPAXUS Stent |
Official FDA classification page: PCU
Classification and pathway per current FDA publications. Data from openFDA (CC0).