510(k) · Cleared
ClearedEndomina EZFuse system
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Endo Tools Therapeutics S.A. · OCW Endoscopic Tissue Approximation Device
Cleared on Feb 13, 2026 as substantially equivalent to K211309 (Endo Tools Therapeutics S.A., 2021) after a 197-day review. Its family tree reaches back 5 generations to 1997.
- Decided
- Feb 13, 2026
- Review
- 197 days
- Class
- Class II
- Product code
- OCW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K972679 (1997). 8 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK972679 Endopath Endoscopic Tissue Fastening System (Etfs)Ethicon Endo-Surgery, Inc. · 1997
- 4 generations backK061770 Ethicon Endo Surgery Endoscopic Suturing SystemEthicon Endo-Surgery, Inc. · 2006
- 3 generations backK081853 Overstitch Endoscopic Suture SystemApollo Endosurgery, Inc. · 2008
- 2 generations backK171886 OverStitch SX Endoscopic Suturing System (ESS)Apollo Endosurgery, Inc. · 2017
- 1 generation backK211309 endomina systemEndo Tools Therapeutics S.A. · 2021
- This deviceK252400 Endomina EZFuse systemEndo Tools Therapeutics S.A. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K972679 | Endopath Endoscopic Tissue Fastening System (Etfs) | Ethicon Endo-Surgery, Inc. | 1997 | — |
| −4 | K061770 | Ethicon Endo Surgery Endoscopic Suturing System | Ethicon Endo-Surgery, Inc. | 2006 | — |
| −3 | K081853 | Overstitch Endoscopic Suture System | Apollo Endosurgery, Inc. | 2008 | — |
| −2 | K171886 | OverStitch SX Endoscopic Suturing System (ESS) | Apollo Endosurgery, Inc. | 2017 | — |
| −1 | K211309 | endomina system | Endo Tools Therapeutics S.A. | 2021 | — |
| 0 (this device) | K252400 | Endomina EZFuse system | Endo Tools Therapeutics S.A. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2001 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in OCW? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new OCW device
- #1 K243750 SimpleStitch Suturing Systemscore 10.1 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K211309 | endomina systemSummary page 6…OCW Classification Name: Endoscope and accessories Regulation Number: 21 CFR 876.1500 Regulatory Class: Class II Predicate Device: K211309 – endomina® system (Endo Tools Therapeutics S.A.) Device Description: The endomina® EZFuse sys… | 2021 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 29 years and passes through 3 companies; a new generation was cleared every 4.2 years on median.
- 1 of the 8 ancestors has a recall of any class.
How does its category compare?
All OCW devicesOCW Endoscopic Tissue Approximation Device: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · OCW
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OCW
133in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OCW
3so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OCW
326in 2025
MAUDE reports naming product code OCW, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 5 | 58 | 0 | 9 |
| 2008 | 4 | 70 | 0 | 47 |
| 2009 | 3 | 30 | 0 | 30 |
| 2010 | 4 | 91 | 0 | 10 |
| 2011 | 1 | — | 0 | 16 |
| 2012 | 1 | — | 0 | 28 |
| 2013 | 2 | — | 0 | 2 |
| 2014 | 0 | — | 0 | 28 |
| 2015 | 0 | — | 0 | 59 |
| 2016 | 2 | — | 0 | 74 |
| 2017 | 2 | — | 0 | 420 |
| 2018 | 2 | — | 0 | 413 |
| 2019 | 1 | — | 0 | 291 |
| 2020 | 1 | — | 0 | 183 |
| 2021 | 3 | 221 | 0 | 198 |
| 2022 | 0 | — | 0 | 235 |
| 2023 | 3 | 133 | 1 | 227 |
| 2024 | 0 | — | 0 | 211 |
| 2025 | 1 | — | 0 | 326 |
| 2026 | 2 | — | 3 | — |
What is it indicated for?
The endomina® EZFuse system is intended for endoscopic placement of suture(s) and approximation of soft tissue in the gastrointestinal tract.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K252400 · printed Nov 6, 2026
Cite this page
510(k) Report. “K252400: Endomina EZFuse system.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K252400
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026