K253987
- 510(k) number
- K253987
- Device name
- BARE Wireguided Balloon Dilation Catheter (1235)
- Applicant
- GIE Medical MN · US
- Product code
- FGE — Stents, Drains And Dilators For The Biliary Ducts
- Decision date
- 2026-03-13
- Date received
- 2025-12-12
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 1.0 MB · U.S. public domain
Also available from FDA: K253987.pdf
Official FDA record: K253987
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.