510(k) · Cleared

Cleared

Connex Gastrointestinal Suture Anchor, Model Gias

K090133510(k) SpecialCleared Feb 20, 200930-day reviewClass II21 CFR 876.5010

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Cook, Inc. · FGE Stents, Drains And Dilators For The Biliary Ducts

Cleared on Feb 20, 2009 as substantially equivalent to K873606 (Cook, Inc., 1988) after a 30-day review. Its family tree reaches back 1 generation to 1988. 3 later devices descend from it.

Decided: Feb 20, 2009
Review: 30 days
Class: Class II
Product code: FGE
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K873606 (1988). 3 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK873606 Modified Cope Suture AnchorCook, Inc. · 1988
This deviceK090133 Connex Gastrointestinal Suture Anchor, Model GiasCook, Inc. · 2009
Descendant · cites it directly · 2 of its ownK131201 Entuit Secure Gastrointestional Suture Anchor Set, Entuit Secure…Cook, Inc. · 2013
Descendant · 2 generations on · 1 of its ownK152524 Entuit Secure Gastrointestinal Suture Anchor Set, Entuit Secure…Cook Incorporated · 2015 · Recalled
Descendant · 3 generations on · 0 of its ownK251229 EndoFix™Tissue Fixation SystemSoftac Medical Technologies · 2025

Most influential descendants

Showing 3 of 3 · See all

K131201Entuit Secure Gastrointestional Suture Anchor Set, Entuit Secure Adjustable…Cook, Inc. · 2013 · cites it directly2descendants
K152524Entuit Secure Gastrointestinal Suture Anchor Set, Entuit Secure Adjustable…Cook Incorporated · 2015 · 2 generations on1descendant
K251229EndoFix™Tissue Fixation SystemSoftac Medical Technologies · 2025 · 3 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K873606	Modified Cope Suture Anchor	Cook, Inc.	1988	—
0 (this device)	K090133	Connex Gastrointestinal Suture Anchor, Model Gias	Cook, Inc.	2009	—
+1	K131201	Entuit Secure Gastrointestional Suture Anchor Set, Entuit Secure Adjustable…	Cook, Inc.	2013	—
+2	K152524	Entuit Secure Gastrointestinal Suture Anchor Set, Entuit Secure Adjustable…	Cook Incorporated	2015	3
+3	K251229	EndoFix™Tissue Fixation System	Softac Medical Technologies	2025	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2013	1	0
2015	1	0
2025	1	0

FIG. 1 — Lineage of K090133, 1988–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

Get a 510(k) 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	Applicant	Decided	Recalls
*	K873606	Modified Cope Suture Anchor Summary page 1 …r one-time use. Substantial Equivalence: The proposed Connex Gastrointestinal Suture Anchor Set is substantial equivalence to the predicate device, Cope Suture Anchor, K873606. The identical indications for use, principles of operations, similar materials of construction and technological characteristics…	Cook, Inc.	1988	—

Also cleared against K873606: 1 other device →

What descends from it? (3)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K131201	Entuit Secure Gastrointestional Suture Anchor Set, Entuit Secure Adjustable…	Cook, Inc.	2013	2

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?

Its one ancestor has no recall.
Of its descendants, K131201 (Cook, Inc., 2013) has gone furthest, with 2 descendants of its own.
1 other device also cites its predicate K873606.

How does its category compare?

All FGE devices

FGE Stents, Drains And Dilators For The Biliary Ducts: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.

FDA decisions per year · FGE

7in 2025

2007high 11 (2008) · low 1 (2021)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FGE

257in 2025

2007high 316 (2007) · low 49 (2016)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · FGE

1in 2024

2007high 93 (2008) · low 0 (2014)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · FGE

1,923in 2025

2007high 2,297 (2021) · low 1,006 (2007)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 Connex 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/K090133 · printed Nov 6, 2026

Cite this page

510(k) Report. “K090133: Connex Gastrointestinal Suture Anchor, Model Gias.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090133

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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