K251229
- 510(k) number
- K251229
- Device name
- EndoFixTissue Fixation System
- Applicant
- Softac Medical Technologies MA · US
- Product code
- FGE — Stents, Drains And Dilators For The Biliary Ducts
- Decision date
- 2025-08-20
- Date received
- 2025-04-21
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K251229.pdf
Official FDA record: K251229
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.