K242845
- 510(k) number
- K242845
- Device name
- EGIS Biliary Double Bare Stent (BDB080405)
- Applicant
- S&G Biotech, Inc. KR
- Product code
- FGE — Stents, Drains And Dilators For The Biliary Ducts
- Decision date
- 2025-06-25
- Date received
- 2024-09-20
- Decision
- Unknown
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K242845.pdf
Official FDA record: K242845
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.