Data / Medical devices / Pancreatic Stent, Covered, Metallic, Removable
Pancreatic Stent, Covered, Metallic, Removable (PCU): 4 FDA-registered makers in 3 countries
4 establishments in 3 countries are registered with the FDA to make Pancreatic Stent, Covered, Metallic, Removable (product code PCU, Class 2, 21 CFR 876.5015). 4 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 11 510(k) clearances under this code, the latest on March 13, 2026, and lists 1 recall event (0 Class I). FDA data exported November 2, 2026.
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- Product code
- PCU
- Device class
- 2
- Regulation
- 876.5015
- Medical specialty
- Gastroenterology, Urology
- Implant
- Yes
Makers by country
| Country | Makers |
|---|---|
| United States | 2 |
| Ireland | 1 |
| South Korea | 1 |
Makers of Pancreatic Stent, Covered, Metallic, Removable
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Boston Scientific Corporation | Marlborough, MA, United States | Specification developer | 1 | March 25, 2019 | 0 | 1 | 0 | api.fda.gov |
| Boston Scientific Corporation | Coventry, RI, United States | Manufacturer | 1 | March 25, 2019 | 0 | 0 | 0 | api.fda.gov |
| Boston Scientific Limited | GALWAY Galway(County), Ireland | Manufacturer | 1 | March 25, 2019 | 0 | 0 | 0 | api.fda.gov |
| Taewoong Medical Co., Ltd | Gimpo-Si Gyeonggi, South Korea | Manufacturer | 1 | March 13, 2026 | 0 | 0 | 0 | api.fda.gov |
Updated March 13, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.