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FDA 510(k)

Endomina EZFuse system

K-Number: K252400 · 2026-02-13

ApplicantEndo Tools Therapeutics S.A.
Decision Date2026-02-13
Product CodeOCW
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Endomina EZFuse system is the device name listed in this FDA 510(k) record. The listed applicant is Endo Tools Therapeutics S.A.. It received FDA 510(k) clearance on 2026-02-13 under 510(k) number K252400. The device is classified under product code OCW. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Endomina EZFuse system?

Endomina EZFuse system is a medical device that received FDA 510(k) clearance on 2026-02-13. The listed applicant is Endo Tools Therapeutics S.A.. The 510(k) number is K252400.

When did Endomina EZFuse system receive FDA 510(k) clearance?

Endomina EZFuse system received FDA 510(k) clearance on 2026-02-13, under 510(k) number K252400.

Who is the listed applicant for Endomina EZFuse system?

The FDA 510(k) record lists Endo Tools Therapeutics S.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Endomina EZFuse system?

The FDA product code for Endomina EZFuse system is OCW.

Other records listing Endo Tools Therapeutics S.A. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K211309endomina system

Related Devices (Code: OCW)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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