510(k) · Cleared

Cleared

Non-Bioabsorbable Staple

K023372510(k) TraditionalCleared Dec 27, 200280-day reviewClass II21 CFR 878.4495

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

Onux Medical, Inc. · NJU Suture, Nonabsorbable, Nitinol

Cleared on Dec 27, 2002 as substantially equivalent to K013749 (Ethicon Endo-Surgery, Inc., 2002) after an 80-day review. Its family tree reaches back 3 generations to 1994. 6 later devices descend from it.

Decided: Dec 27, 2002
Review: 80 days
Class: Class II
Product code: NJU
Recalls: None
Predicates: 1

Its longest line of descent runs back 3 generations to K944415 (1994). 4 ancestors in all, the oldest K913469 (1991). 6 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 3 generations backK944415 Origin Tacker SystemOrigin Medsystems, Inc. · 1994
2 generations backK963999 Auto Suture* Modified Endoscopic Fascia Stapler** DeviceUnited States Surgical, A Division of Tyco Healthc · 1996 · Recalled
1 generation backK013749 Endoanchor and OpenanchorEthicon Endo-Surgery, Inc. · 2002
This deviceK023372 Non-Bioabsorbable StapleOnux Medical, Inc. · 2002
Descendant · cites it directly · 5 of its ownK061276 G-Prox Endoscopic GrasperUsgi Medical · 2006
Descendant · 2 generations on · 1 of its ownK100251 G-Cath Tissue Anchor Delivery Catheter, Models 205302, 205333Usgi Medical · 2010
Descendant · 2 generations on · 1 of its ownK093018 G-Prox Endoscopic Grasper, Model 205333Usgi Medical · 2009
Descendant · 3 generations on · 0 of its ownK103688 G-Prox EZ Endoscopic GrasperUsgi Medical · 2011
Descendant · 2 generations on · 0 of its ownK102931 G-Cinch Suture GrasperUsgi Medical · 2010

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2006high 3 (2010) · low 0 (2007)2026

Most influential descendants

Showing 5 of 6 · See all

K061276G-Prox Endoscopic GrasperUsgi Medical · 2006 · cites it directly5descendants
K100251G-Cath Tissue Anchor Delivery Catheter, Models 205302, 205333Usgi Medical · 2010 · 2 generations on1descendant
K093018G-Prox Endoscopic Grasper, Model 205333Usgi Medical · 2009 · 2 generations on1descendant
K103688G-Prox EZ Endoscopic GrasperUsgi Medical · 2011 · 3 generations on0descendants
K102931G-Cinch Suture GrasperUsgi Medical · 2010 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K944415	Origin Tacker System	Origin Medsystems, Inc.	1994	—
−2	K963999	Auto Suture* Modified Endoscopic Fascia Stapler** Device	United States Surgical, A Division of Tyco Healthc	1996	1
−1	K013749	Endoanchor and Openanchor	Ethicon Endo-Surgery, Inc.	2002	—
0 (this device)	K023372	Non-Bioabsorbable Staple	Onux Medical, Inc.	2002	—
+1	K061276	G-Prox Endoscopic Grasper	Usgi Medical	2006	—
+2	K100251	G-Cath Tissue Anchor Delivery Catheter, Models 205302, 205333	Usgi Medical	2010	—
+2	K093018	G-Prox Endoscopic Grasper, Model 205333	Usgi Medical	2009	—
+3	K103688	G-Prox EZ Endoscopic Grasper	Usgi Medical	2011	—
+2	K102931	G-Cinch Suture Grasper	Usgi Medical	2010	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1991	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2006	1	0
2009	1	0
2010	3	0
2011	1	0

FIG. 1 — Lineage of K023372, 1994–2011Source: 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 NJU? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Candidate predicates for a device like this, rankedin the report
Recall history across each candidate’s familyin 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
*	K013749	Endoanchor and Openanchor	Ethicon Endo-Surgery, Inc.	2002	—

Also cleared against K013749: 1 other device →

What descends from it? (6)

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

Number	Device	Applicant	Decided	Descendants
K061276	G-Prox Endoscopic Grasper	Usgi Medical	2006	5

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 8 years and passes through 4 companies; a new generation was cleared every 2.0 years on median.
1 of the 4 ancestors has a recall of any class.
Of its descendants, K061276 (Usgi Medical, 2006) has gone furthest, with 5 descendants of its own.
1 other device also cites its predicate K013749.

How does its category compare?

All NJU devices

NJU Suture, Nonabsorbable, Nitinol: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · NJU

FDA has decided no NJU device since 2007.

Median 510(k) review, days · NJU

Too few NJU 510(k)s in any year since 2007 to give a median.

Recalls per year · NJU

No recall names NJU since 2007.

Adverse event reports per year · NJU

No MAUDE report names NJU since 2007.

View these four charts as a table

Year	Median 510(k) review, days	MAUDE reports
2007	—	0
2008	—	0
2009	—	0
2010	—	0
2011	—	0
2012	—	0
2013	—	0
2014	—	0
2015	—	0
2016	—	0
2017	—	0
2018	—	0
2019	—	0
2020	—	0
2021	—	0
2022	—	0
2023	—	0
2024	—	0
2025	—	0
2026	—	—

What is it indicated for?

The Coil Fixation Device is intended for fixation of prosthetic material and approximation of tissue in endoscopic and open surgical procedures.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K023372 · printed Nov 6, 2026

Cite this page

510(k) Report. “K023372: Non-Bioabsorbable Staple.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023372

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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