K252400
- 510(k) number
- K252400
- Device name
- Endomina EZFuse system
- Applicant
- Endo Tools Therapeutics S.A. BE
- Product code
- OCW — Endoscopic Tissue Approximation Device
- Decision date
- 2026-02-13
- Date received
- 2025-07-31
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 0.3 MB · U.S. public domain
Also available from FDA: K252400.pdf
Official FDA record: K252400
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.