K223354
- 510(k) number
- K223354
- Device name
- EGIS Biliary Single Bare Stent
- Applicant
- S&G Biotech, Inc. KR
- Product code
- FGE — Stents, Drains And Dilators For The Biliary Ducts
- Decision date
- 2023-09-21
- Date received
- 2022-11-02
- 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: K223354.pdf
Official FDA record: K223354
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.