510(k) · Cleared
ClearedModified Cope Suture Anchor
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 Jun 17, 1988 after a 283-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 7 later devices descend from it.
- Decided
- Jun 17, 1988
- Review
- 283 days
- Class
- Class II
- Product code
- FGE
- Recalls
- None
- Predicates
- 0
7 later devices descend from it, 2 citing it directly.
- This deviceK873606 Modified Cope Suture AnchorCook, Inc. · 1988
- Descendant · cites it directly · 3 of its ownK090133 Connex Gastrointestinal Suture Anchor, Model GiasCook, Inc. · 2009
- Descendant · cites it directly · 2 of its ownK182832 Cope Pediatric Gastrointestinal Suture Anchor Set, Enterostomy…Cook Incorporated · 2019
- Descendant · 2 generations on · 2 of its ownK131201 Entuit Secure Gastrointestional Suture Anchor Set, Entuit Secure…Cook, Inc. · 2013
- Descendant · 2 generations on · 1 of its ownK193612 AMT Suture Delivery SystemApplied Medical Technology, Inc. · 2020
- Descendant · 3 generations on · 1 of its ownK152524 Entuit Secure Gastrointestinal Suture Anchor Set, Entuit Secure…Cook Incorporated · 2015 · Recalled
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K090133Connex Gastrointestinal Suture Anchor, Model GiasCook, Inc. · 2009 · cites it directly3descendants
- K182832Cope Pediatric Gastrointestinal Suture Anchor Set, Enterostomy Suture Anchor SetCook Incorporated · 2019 · cites it directly2descendants
- K131201Entuit Secure Gastrointestional Suture Anchor Set, Entuit Secure Adjustable…Cook, Inc. · 2013 · 2 generations on2descendants
- K193612AMT Suture Delivery SystemApplied Medical Technology, Inc. · 2020 · 2 generations on1descendant
- K152524Entuit Secure Gastrointestinal Suture Anchor Set, Entuit Secure Adjustable…Cook Incorporated · 2015 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K873606 | Modified Cope Suture Anchor | Cook, Inc. | 1988 | — |
| +1 | K090133 | Connex Gastrointestinal Suture Anchor, Model Gias | Cook, Inc. | 2009 | — |
| +1 | K182832 | Cope Pediatric Gastrointestinal Suture Anchor Set, Enterostomy Suture Anchor Set | Cook Incorporated | 2019 | — |
| +2 | K131201 | Entuit Secure Gastrointestional Suture Anchor Set, Entuit Secure Adjustable… | Cook, Inc. | 2013 | — |
| +2 | K193612 | AMT Suture Delivery System | Applied Medical Technology, Inc. | 2020 | — |
| +3 | K152524 | Entuit Secure Gastrointestinal Suture Anchor Set, Entuit Secure Adjustable… | Cook Incorporated | 2015 | 3 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (7)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K090133 (Cook, Inc., 2009) has gone furthest, with 3 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.
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 | — |
https://510kreport.com/device/K873606 · printed Nov 6, 2026
Cite this page
510(k) Report. “K873606: Modified Cope Suture Anchor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K873606
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026