Endomina EZFuse system
FDA 510(k) K252400 · Endo Tools Therapeutics S.A.
510(k) numberK252400
Submission
- Device name
- Endomina EZFuse system
- Applicant
- Endo Tools Therapeutics S.A.
Gosselies, BE - Received
- July 31, 2025
- Decision date
- February 13, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OCW – Endoscopic Tissue Approximation Device
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
To aid in endoscopically placing sutures, staples, clips, and other fastening tools through tissue.
Other 510(k)s with product code OCW
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K243750 | SimpleStitch Suturing SystemOCW · Traditional | Envision Endoscopy | 04/17/2025SE |
| K231240 | MaxTack Motorized Fixation DeviceOCW · Traditional | Covidien | 09/08/2023SE |
| K213271 | MedicloseTM SystemOCW · Traditional | Health Value Creation B.V., Trading AS Corporis… | 08/31/2023SE |
| K231553 | OverStitch NXT Endoscopic Suturing SystemOCW · Special | Apollo Endosurgery, Inc. | 06/29/2023SE |
| K211309 | endomina systemOCW · Traditional | Endo Tools Therapeutics S.A. | 12/07/2021SE |
| K201744 | Su2ura Approximation DeviceOCW · Traditional | Anchora Medical, Ltd. | 06/17/2021SE |
| K210266 | OverStitch Sx Endoscopic Suturing SystemOCW · Special | Apollo Endosurgery, Inc. | 03/02/2021SE |
| K193652 | AbClose - Port Site Closure DeviceOCW · Traditional | Medeon Biodesign, Inc. | 03/26/2020SE |
| K191439 | OverStitch 2-0 Polypropylene SutureOCW · Traditional | Apollo Endosurgery | 08/29/2019SE |
| K181141 | OverStitch Endoscopic Suturing System and AccessoriesOCW · Special | Apollo Endosurgery | 06/27/2018SE |
More from Apollo Endosurgery
| 510(k) | Device | Decision |
|---|---|---|
| K211309 | endomina systemOCW · Traditional | 12/07/2021SE |
Questions and answers
When was Endomina EZFuse system cleared by the FDA?
Endomina EZFuse system (K252400) received a 510(k) decision of Substantially Equivalent on February 13, 2026, 197 days after the submission was received.
What is the product code of K252400?
The FDA product code is OCW – Endoscopic Tissue Approximation Device, a Class II (moderate risk) device regulated under 21 CFR 876.1500.