Endomina EZFuse system— 510(k) K252400
Substantially EquivalentEndo Tools Therapeutics S.A.
FDA 510(k) clearance K252400 for Endomina EZFuse system, Substantially Equivalent on 2026-02-13. Applicant: Endo Tools Therapeutics S.A.. Device class: 2.
Summary
Endo Tools Therapeutics' Endomina EZFuse system is filed under product code OCW, endoscopic tissue approximation device. The record doesn't describe the system beyond its name and that code name.
Class II, 21 CFR 876.1500. Gastroenterology, Urology is both the classification panel and the review panel, and it came in as a Traditional 510(k).
Endo Tools Therapeutics filed from Gosselies, Belgium. The substantially equivalent decision came 197 calendar days after receipt (July 31, 2025 to February 13, 2026).
Clearance details
- Applicant
- Endo Tools Therapeutics S.A.
- Product code
- Product code OCW
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Gosselies, BE
Recent devices under product code OCW
view allMore clearances from Endo Tools Therapeutics S.A.
view allAdverse events under product code OCW
product code OCW- Death
- 6
- Injury
- 443
- Malfunction
- 1,023
- Other
- 2
- Total
- 1,474
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.