510(k) · Cleared
ClearedEntuit Secure Gastrointestional Suture Anchor Set, Entuit Secure Adjustable Gastrointestinal Suture Anchor Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cook, Inc. · FGE Stents, Drains And Dilators For The Biliary Ducts
Cleared on Oct 7, 2013 as substantially equivalent to K090133 (Cook, Inc., 2009) after a 161-day review. Its family tree reaches back 2 generations to 1988. 2 later devices descend from it.
- Decided
- Oct 7, 2013
- Review
- 161 days
- Class
- Class II
- Product code
- FGE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K873606 (1988). 2 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK873606 Modified Cope Suture AnchorCook, Inc. · 1988
- 1 generation backK090133 Connex Gastrointestinal Suture Anchor, Model GiasCook, Inc. · 2009
- This deviceK131201 Entuit Secure Gastrointestional Suture Anchor Set, Entuit Secure…Cook, Inc. · 2013
- Descendant · cites it directly · 1 of its ownK152524 Entuit Secure Gastrointestinal Suture Anchor Set, Entuit Secure…Cook Incorporated · 2015 · Recalled
- Descendant · 2 generations on · 0 of its ownK251229 EndoFix™Tissue Fixation SystemSoftac Medical Technologies · 2025
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K873606 | Modified Cope Suture Anchor | Cook, Inc. | 1988 | — |
| −1 | K090133 | Connex Gastrointestinal Suture Anchor, Model Gias | Cook, Inc. | 2009 | — |
| 0 (this device) | K131201 | Entuit Secure Gastrointestional Suture Anchor Set, Entuit Secure Adjustable… | Cook, Inc. | 2013 | — |
| +1 | K152524 | Entuit Secure Gastrointestinal Suture Anchor Set, Entuit Secure Adjustable… | Cook Incorporated | 2015 | 3 |
| +2 | K251229 | EndoFix™Tissue Fixation System | Softac Medical Technologies | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2025 | 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 FGE? 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 FGE device
- #1 K240464 WallFlex Biliary RX Stent System; Epic Biliary…score 14.5 · 13 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 |
|---|---|---|---|
| * | K090133 | Connex Gastrointestinal Suture Anchor, Model GiasSummary page 2…rm Secure Adjustable Gastrointestinal Suture Anchor Set are substantially equivalent to the Connex Gastrointestinal Suture Anchor Set, subject of Premarket Notification K090133, manufactured by Cook Incorporated and cleared for commercial distribution on January 20, 2009. Comparison to Predicate Device:… | 2009 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K152524 | Entuit Secure Gastrointestinal Suture Anchor Set, Entuit Secure Adjustable… | 2015 | 1 |
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 25 years and passes through 1 company; a new generation was cleared every 20.7 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K152524 (Cook Incorporated, 2015) has gone furthest, with 1 descendant of its own.
How does its category compare?
All FGE devicesFGE Stents, Drains And Dilators For The Biliary Ducts: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · FGE
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FGE
257in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FGE
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FGE
1,923in 2025
MAUDE reports naming product code FGE, 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 | 4 | 316 | 54 | 1,006 |
| 2008 | 11 | 214 | 93 | 1,465 |
| 2009 | 7 | 160 | 18 | 1,655 |
| 2010 | 9 | 81 | 32 | 1,434 |
| 2011 | 9 | 114 | 2 | 1,321 |
| 2012 | 8 | 96 | 4 | 1,183 |
| 2013 | 5 | 161 | 3 | 1,060 |
| 2014 | 8 | 156 | 0 | 1,270 |
| 2015 | 8 | 79 | 0 | 1,543 |
| 2016 | 4 | 49 | 0 | 1,453 |
| 2017 | 9 | 59 | 1 | 1,515 |
| 2018 | 7 | 215 | 43 | 1,681 |
| 2019 | 2 | — | 13 | 1,896 |
| 2020 | 4 | 121 | 1 | 2,182 |
| 2021 | 1 | — | 27 | 2,297 |
| 2022 | 6 | 101 | 21 | 1,749 |
| 2023 | 6 | 199 | 19 | 1,615 |
| 2024 | 6 | 188 | 1 | 1,948 |
| 2025 | 7 | 257 | 0 | 1,923 |
| 2026 | 8 | 153 | 11 | — |
What is it indicated for?
The Entuit™ Secure Gastrointestinal Suture Anchor Set is intended for anchoring the anterior wall of the stomach to the abdominal wall prior to introduction of interventional catheters.
The Entuit Secure Adjustable Gastrointestinal Suture Anchor Set is intended for anchoring the anterior wall of the stomach to the abdominal wall prior to introduction of interventional catheters.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K131201 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131201: Entuit Secure Gastrointestional Suture Anchor Set, Entuit Secure Adjustable Gastrointestinal Suture Anchor Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131201
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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