510(k) · Cleared
Recalled · Class II · 2024Entuit Secure Gastrointestinal 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 Incorporated · FGE Stents, Drains And Dilators For The Biliary Ducts
Cleared on Sep 30, 2015 as substantially equivalent to K131201 (Cook, Inc., 2013) after a 27-day review. Its family tree reaches back 3 generations to 1988. 1 later device descends from it. It has been recalled 3 times.
- Decided
- Sep 30, 2015
- Review
- 27 days
- Class
- Class II
- Product code
- FGE
- Recalls
- 3
- Predicates
- 1
Its longest line of descent runs back 3 generations to K873606 (1988). 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK873606 Modified Cope Suture AnchorCook, Inc. · 1988
- 2 generations backK090133 Connex Gastrointestinal Suture Anchor, Model GiasCook, Inc. · 2009
- 1 generation backK131201 Entuit Secure Gastrointestional Suture Anchor Set, Entuit Secure…Cook, Inc. · 2013
- This deviceK152524 Entuit Secure Gastrointestinal Suture Anchor Set, Entuit Secure…Cook Incorporated · 2015
- Descendant · cites it directly · 0 of its ownK251229 EndoFix™Tissue Fixation SystemSoftac Medical Technologies · 2025
Most influential descendants
Showing 1 of 1 · See all- K251229EndoFix™Tissue Fixation SystemSoftac Medical Technologies · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K873606 | Modified Cope Suture Anchor | Cook, Inc. | 1988 | — |
| −2 | K090133 | Connex Gastrointestinal Suture Anchor, Model Gias | Cook, Inc. | 2009 | — |
| −1 | K131201 | Entuit Secure Gastrointestional Suture Anchor Set, Entuit Secure Adjustable… | Cook, Inc. | 2013 | — |
| 0 (this device) | K152524 | Entuit Secure Gastrointestinal Suture Anchor Set, Entuit Secure Adjustable… | Cook Incorporated | 2015 | — |
| +1 | K251229 | EndoFix™Tissue Fixation System | Softac Medical Technologies | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K131201 | Entuit Secure Gastrointestional Suture Anchor Set, Entuit Secure Adjustable…Summary page 4…sification Name: Catheter, Biliary, Diagnostic Regulation: 21 CFR §876.5010 Product Code FGE Predicate Device: x K131201, EntuitTM Secure Gastrointestinal Suture Anchor Set and the EntuitTM Secure Adjustable Gastrointestinal Suture Anchor Set… | 2013 |
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 |
|---|---|---|---|
| K251229 | EndoFix™Tissue Fixation System | 2025 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 1, 2024 | Class II | Z-1529-2024 | Under Investigation by firm | Packaging may have low seal strength and not meet peel strength specifications, compromising device sterility |
| Dec 19, 2018 | Class II | Z-0968-2019 | Under Investigation by firm | There is a potential for difficulty in sliding down the retention mechanism on the sets manufactured with a specific extension spring lot. |
| Dec 19, 2018 | Class II | Z-0967-2019 | Under Investigation by firm | There is a potential for difficulty in sliding down the retention mechanism on the sets manufactured with a specific extension spring lot. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 27 years and passes through 2 companies; a new generation was cleared every 4.6 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K251229 (Softac Medical Technologies, 2025) has gone furthest, with 0 descendants 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. 2015, 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K152524 · printed Nov 6, 2026
Cite this page
510(k) Report. “K152524: Entuit Secure Gastrointestinal 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/K152524
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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