K241801
- 510(k) number
- K241801
- Device name
- Tornus ES
- Applicant
- Asahi Intecc Co., Ltd. JP
- Product code
- FGE — Stents, Drains And Dilators For The Biliary Ducts
- Decision date
- 2024-12-17
- Date received
- 2024-06-21
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 0.7 MB · U.S. public domain
Also available from FDA: K241801.pdf
Official FDA record: K241801
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.