510(k) · Cleared
Clearedendomina 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 Dec 7, 2021 as substantially equivalent to K171886 (Apollo Endosurgery, Inc., 2017) after a 221-day review. Its family tree reaches back 4 generations to 1997. 1 later device descends from it.
- Decided
- Dec 7, 2021
- Review
- 221 days
- Class
- Class II
- Product code
- OCW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K972679 (1997). 7 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK972679 Endopath Endoscopic Tissue Fastening System (Etfs)Ethicon Endo-Surgery, Inc. · 1997
- 3 generations backK061770 Ethicon Endo Surgery Endoscopic Suturing SystemEthicon Endo-Surgery, Inc. · 2006
- 2 generations backK081853 Overstitch Endoscopic Suture SystemApollo Endosurgery, Inc. · 2008
- 1 generation backK171886 OverStitch SX Endoscopic Suturing System (ESS)Apollo Endosurgery, Inc. · 2017
- This deviceK211309 endomina systemEndo Tools Therapeutics S.A. · 2021
- Descendant · cites it directly · 0 of its ownK252400 Endomina EZFuse systemEndo Tools Therapeutics S.A. · 2026
Most influential descendants
Showing 1 of 1 · See all- K252400Endomina EZFuse systemEndo Tools Therapeutics S.A. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K972679 | Endopath Endoscopic Tissue Fastening System (Etfs) | Ethicon Endo-Surgery, Inc. | 1997 | — |
| −3 | K061770 | Ethicon Endo Surgery Endoscopic Suturing System | Ethicon Endo-Surgery, Inc. | 2006 | — |
| −2 | K081853 | Overstitch Endoscopic Suture System | Apollo Endosurgery, Inc. | 2008 | — |
| −1 | K171886 | OverStitch SX Endoscopic Suturing System (ESS) | Apollo Endosurgery, Inc. | 2017 | — |
| 0 (this device) | K211309 | endomina system | Endo Tools Therapeutics S.A. | 2021 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 1 | 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 K252400 Endomina EZFuse systemscore 12.0 · 5 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 |
|---|---|---|---|
| * | K171886 | OverStitch SX Endoscopic Suturing System (ESS)Summary page 4…y Class: Class II (21 CFR 876.1500) Product Code: OCW Predicate Device: K171886 – OverStitch™ Endoscopic Suturing System (Apollo Endosurgery) Device Descripti… | 2017 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K252400 | Endomina EZFuse system | 2026 | 0 |
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 24 years and passes through 3 companies; a new generation was cleared every 9.0 years on median.
- 1 of the 7 ancestors has a recall of any class.
- Of its descendants, K252400 (Endo Tools Therapeutics S.A., 2026) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K171886.
How does its category compare?
All OCW devicesOCW Endoscopic Tissue Approximation Device: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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® system, composed of a triangulation platform (endomina® platform) and an instrument for tissue piercing and approximation (TAPES), is intended for endoscopic placement of suture(s) and approximation of soft tissue in the gastrointestinal tract. The system is to be used on an adult population.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K211309 · printed Nov 6, 2026
Cite this page
510(k) Report. “K211309: endomina system.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K211309
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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