510(k) · Cleared

Cleared

Endopath Endoscopic Tissue Fastening System (Etfs)

K980022510(k) TraditionalCleared Mar 9, 199863-day reviewClass II21 CFR 876.1500

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

Ethicon Endo-Surgery, Inc. · GCJ Laparoscope, General & Plastic Surgery

Cleared on Mar 9, 1998 as substantially equivalent to K972679 (Ethicon Endo-Surgery, Inc., 1997) after a 63-day review. Its family tree reaches back 1 generation to 1997. 25 later devices descend from it.

Decided: Mar 9, 1998
Review: 63 days
Class: Class II
Product code: GCJ
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K972679 (1997). 25 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 1 generation backK972679 Endopath Endoscopic Tissue Fastening System (Etfs)Ethicon Endo-Surgery, Inc. · 1997
This deviceK980022 Endopath Endoscopic Tissue Fastening System (Etfs)Ethicon Endo-Surgery, Inc. · 1998
Descendant · cites it directly · 23 of its ownK994290 Bard Endoscopic Suturing SystemC.R. Bard, Inc. · 2000
Descendant · 2 generations on · 21 of its ownK062875 Endogastric Stomaphyx Device and AccessoriesEndogastric Solutions, Inc. · 2007
Descendant · 2 generations on · 15 of its ownK071651 Egs Serosafuse Implantable Fasteners, Associated Delivery Devices…Endogastric Solutions, Inc. · 2007
Descendant · 3 generations on · 6 of its ownK092400 Endogastric Solutions ESOPHYX2 System with Serosafuse Fastener and…Endogastric Solutions, Inc. · 2009 · Recalled
Descendant · 4 generations on · 5 of its ownK142113 ESOPHYX2 HDEndogastric Solutions, Inc. · 2014

Showing 5 of 25 descendants. See all descendants

Descendants cleared per year

1999high 3 (2007) · low 0 (2002)2026

Most influential descendants

Showing 5 of 25 · See all

K994290Bard Endoscopic Suturing SystemC.R. Bard, Inc. · 2000 · cites it directly23descendants
K062875Endogastric Stomaphyx Device and AccessoriesEndogastric Solutions, Inc. · 2007 · 2 generations on21descendants
K071651Egs Serosafuse Implantable Fasteners, Associated Delivery Devices and AccessoriesEndogastric Solutions, Inc. · 2007 · 2 generations on15descendants
K092400Endogastric Solutions ESOPHYX2 System with Serosafuse Fastener and Accessories, Model…Endogastric Solutions, Inc. · 2009 · 3 generations on6descendants
K142113ESOPHYX2 HDEndogastric Solutions, Inc. · 2014 · 4 generations on5descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K972679	Endopath Endoscopic Tissue Fastening System (Etfs)	Ethicon Endo-Surgery, Inc.	1997	—
0 (this device)	K980022	Endopath Endoscopic Tissue Fastening System (Etfs)	Ethicon Endo-Surgery, Inc.	1998	—
+1	K994290	Bard Endoscopic Suturing System	C.R. Bard, Inc.	2000	—
+2	K062875	Endogastric Stomaphyx Device and Accessories	Endogastric Solutions, Inc.	2007	—
+2	K071651	Egs Serosafuse Implantable Fasteners, Associated Delivery Devices and…	Endogastric Solutions, Inc.	2007	—
+3	K092400	Endogastric Solutions ESOPHYX2 System with Serosafuse Fastener and…	Endogastric Solutions, Inc.	2009	2
+4	K142113	ESOPHYX2 HD	Endogastric Solutions, Inc.	2014	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1999	1	0
2000	1	0
2001	1	0
2007	3	0
2008	2	0
2009	2	0
2010	3	0
2011	1	0
2012	2	0
2014	2	0
2015	3	0
2016	1	0
2017	2	0
2024	1	0

FIG. 1 — Lineage of K980022, 1997–2024Source: 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 GCJ? 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 GCJ device

#1 K214046 780 nm 1688 4K Camera System, 780 nm L11 LED…score 21.4 · 21 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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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
*	K972679	Endopath Endoscopic Tissue Fastening System (Etfs) Summary page 1 …mmon Name: Knot Tying Instrument Trade Name/Proprietary Name: ENDOPATH® Endoscopic Tissue Fastening System (ETES) ENDOPATH® Endoscopic Tissue Fastening System (ETFS) (K972679). All device functions, scientific concepts, significant physical and performance characteristics (i.e. device design, materials…	Ethicon Endo-Surgery, Inc.	1997	—

Also cleared against K972679: 2 other devices →

What descends from it? (25)

See all 25

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K994290	Bard Endoscopic Suturing System	C.R. Bard, Inc.	2000	23
K992612	Endopath Endoscopic Tissue Fastening System with Coated Vicryl, Models SW210, SW220…	Ethicon Endo-Surgery, Inc.	1999	0

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, K994290 (C.R. Bard, Inc., 2000) has gone furthest, with 23 descendants of its own.
2 other devices also cite its predicate K972679.

How does its category compare?

All GCJ devices

GCJ Laparoscope, General & Plastic Surgery: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GCJ

21in 2025

2007high 31 (2023) · low 15 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GCJ

108in 2025

2007high 122 (2010) · low 42 (2007)2026

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

Recalls per year · GCJ

5in 2025

2007high 30 (2010) · low 0 (2015)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · GCJ

5,860in 2025

2007high 6,047 (2024) · low 1,319 (2008)2025

MAUDE reports naming product code GCJ, 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	18	42	12	1,639
2008	19	73	16	1,319
2009	21	85	6	1,995
2010	24	122	30	2,657
2011	15	113	9	2,133
2012	17	88	1	1,526
2013	15	93	7 (1)	1,565
2014	19	90	2	1,714
2015	26	76	0	1,710
2016	27	99	5	2,080
2017	20	77	1	3,468
2018	21	88	1	2,562
2019	15	60	0	2,578
2020	28	61	0	2,618
2021	18	116	0	3,431
2022	20	103	1	3,945
2023	31	109	1	6,002
2024	29	90	0	6,047
2025	21	108	5	5,860
2026	26	122	1	—

What is it indicated for?

The ENDOPATH® Endoscopic Tissue Fastening System (ETFS) is intended for use in minimally invasive surgical applications where soft tissue is being approximated with interrupted stitches.

ETHIBOND EXCEL Polyester Suture is intended for usc in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures.

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/K980022 · printed Nov 4, 2026

Cite this page

510(k) Report. “K980022: Endopath Endoscopic Tissue Fastening System (Etfs).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K980022

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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