Cleared Traditional

K252400 - Endomina EZFuse system (FDA 510(k) Clearance)

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K252400 · Endo Tools Therapeutics S.A. · Gastroenterology & Urology device
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Feb 2026
Decision
197d
Days
Class 2
Risk

K252400 is an FDA 510(k) clearance for the Endomina EZFuse system. Classified as Endoscopic Tissue Approximation Device (product code OCW), Class II - Special Controls.

Submitted by Endo Tools Therapeutics S.A. (Gosselies, BE). The FDA issued a Cleared decision on February 13, 2026 after a review of 197 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1500 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Endo Tools Therapeutics S.A. devices

Submission Details

510(k) Number K252400 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 31, 2025
Decision Date February 13, 2026
Days to Decision 197 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
67d slower than avg
Panel avg: 130d · This submission: 197d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OCW Endoscopic Tissue Approximation Device
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition To Aid In Endoscopically Placing Sutures, Staples, Clips, And Other Fastening Tools Through Tissue.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - OCW Endoscopic Tissue Approximation Device

All 69
Devices cleared under the same product code (OCW) and FDA review panel - the closest regulatory comparables to K252400.
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endomina system
K211309 · Endo Tools Therapeutics S.A. · Dec 2021
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K201744 · Anchora Medical, Ltd. · Jun 2021