510(k) · Cleared

Cleared

Ethicon Endo Surgery Endoscopic Suturing System

K061770510(k) TraditionalCleared Sep 25, 200694-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. · OCW Endoscopic Tissue Approximation Device

Cleared on Sep 25, 2006 as substantially equivalent to K003956 (C.R. Bard, Inc., 2001) and 2 other predicates after a 94-day review. Its family tree reaches back 1 generation to 1997. 14 later devices descend from it.

Decided: Sep 25, 2006
Review: 94 days
Class: Class II
Product code: OCW
Recalls: None
Predicates: 3

Its longest line of descent runs back 1 generation to K972679 (1997). 3 ancestors in all. 14 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 deviceK061770 Ethicon Endo Surgery Endoscopic Suturing SystemEthicon Endo-Surgery, Inc. · 2006
Descendant · cites it directly · 8 of its ownK081853 Overstitch Endoscopic Suture SystemApollo Endosurgery, Inc. · 2008
Descendant · 2 generations on · 7 of its ownK171886 OverStitch SX Endoscopic Suturing System (ESS)Apollo Endosurgery, Inc. · 2017
Descendant · cites it directly · 4 of its ownK070151 Inscope Tissue Anchors, Knotting Elements and Tissue Anchor and…Ethicon Endo-Surgery, LLC · 2007
Descendant · 3 generations on · 3 of its ownK181141 OverStitch Endoscopic Suturing System and AccessoriesApollo Endosurgery · 2018 · Recalled
Descendant · 2 generations on · 3 of its ownK073671 Plicator GSX Suturing System, Plicator GSX, Plicator Instrument…Ndo Surgical, Inc. · 2008

Showing 5 of 14 descendants. See all descendants

Descendants cleared per year

2007high 2 (2008) · low 0 (2009)2026

Most influential descendants

Showing 5 of 14 · See all

K081853Overstitch Endoscopic Suture SystemApollo Endosurgery, Inc. · 2008 · cites it directly8descendants
K171886OverStitch SX Endoscopic Suturing System (ESS)Apollo Endosurgery, Inc. · 2017 · 2 generations on7descendants
K070151Inscope Tissue Anchors, Knotting Elements and Tissue Anchor and Knotting Element ApplierEthicon Endo-Surgery, LLC · 2007 · cites it directly4descendants
K181141OverStitch Endoscopic Suturing System and AccessoriesApollo Endosurgery · 2018 · 3 generations on3descendants
K073671Plicator GSX Suturing System, Plicator GSX, Plicator Instrument, Plicator GSX Suture…Ndo Surgical, Inc. · 2008 · 2 generations on3descendants

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)	K061770	Ethicon Endo Surgery Endoscopic Suturing System	Ethicon Endo-Surgery, Inc.	2006	—
+1	K081853	Overstitch Endoscopic Suture System	Apollo Endosurgery, Inc.	2008	—
+2	K171886	OverStitch SX Endoscopic Suturing System (ESS)	Apollo Endosurgery, Inc.	2017	—
+1	K070151	Inscope Tissue Anchors, Knotting Elements and Tissue Anchor and Knotting…	Ethicon Endo-Surgery, LLC	2007	—
+3	K181141	OverStitch Endoscopic Suturing System and Accessories	Apollo Endosurgery	2018	2
+2	K073671	Plicator GSX Suturing System, Plicator GSX, Plicator Instrument, Plicator GSX…	Ndo Surgical, Inc.	2008	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2001	2	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2007	1	0
2008	2	0
2010	1	0
2011	1	0
2012	1	0
2017	1	0
2018	1	0
2019	1	0
2021	2	0
2023	1	0
2025	1	0
2026	1	0

FIG. 1 — Lineage of K061770, 1997–2026Source: 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 OCW? 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 OCW device

#1 K252400 Endomina EZFuse systemscore 12.0 · 5 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? (3)

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
*	K003956	Bard Endocinch Suturing System # 000452; 000454; 000595 Summary page 1 …Classification Name: Endoscopes and accessories [21 CFR 876.1500 (KOG)] Predicate Devices Bard® EndoCinch TM Suturing System (K003956) ENDOPATH® Endoscopic Tissue Fastening System (K972679) LSI Solutions Flexible Suture Placeme…	C.R. Bard, Inc.	2001	—
*	K972679	Endopath Endoscopic Tissue Fastening System (Etfs) Summary page 1 …[21 CFR 876.1500 (KOG)] Predicate Devices Bard® EndoCinch TM Suturing System (K003956) ENDOPATH® Endoscopic Tissue Fastening System (K972679) LSI Solutions Flexible Suture Placement Device and Acc. (K0l 1016) Device Description The Ethicon Endo Surgery…	Ethicon Endo-Surgery, Inc.	1997	—
*	K011016	Lsi Solutions Flexible Suture Placement Device and Accessories Product	Lsi Solutions	2001	1

Also cleared against K003956: 5 other devices →

What descends from it? (14)

See all 14

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

Number	Device	Applicant	Decided	Descendants
K081853	Overstitch Endoscopic Suture System	Apollo Endosurgery, Inc.	2008	8
K070151	Inscope Tissue Anchors, Knotting Elements and Tissue Anchor and Knotting Element Applier	Ethicon Endo-Surgery, LLC	2007	4

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?

1 of the 3 ancestors has a recall of any class.
Of its descendants, K081853 (Apollo Endosurgery, Inc., 2008) has gone furthest, with 8 descendants of its own.
5 other devices also cite its predicate K003956.

How does its category compare?

All OCW devices

OCW Endoscopic Tissue Approximation Device: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · OCW

1in 2025

2007high 5 (2007) · low 0 (2014)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · OCW

133in 2023

2007high 221 (2021) · low 30 (2009)2026

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

Recalls per year · OCW

3so far in 2026, the most since 2007

2007high 3 (2026) · low 0 (2007)2026

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

Adverse event reports per year · OCW

326in 2025

2007high 420 (2017) · low 2 (2013)2025

MAUDE reports naming product code OCW, 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	5	58	0	9
2008	4	70	0	47
2009	3	30	0	30
2010	4	91	0	10
2011	1	—	0	16
2012	1	—	0	28
2013	2	—	0	2
2014	0	—	0	28
2015	0	—	0	59
2016	2	—	0	74
2017	2	—	0	420
2018	2	—	0	413
2019	1	—	0	291
2020	1	—	0	183
2021	3	221	0	198
2022	0	—	0	235
2023	3	133	1	227
2024	0	—	0	211
2025	1	—	0	326
2026	2	—	3	—

What is it indicated for?

The Ethicon Endo Surgery® Endoscopic Suturing System is indicated for endoscopic placement of suture(s) and approximation of soft tissue.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K061770 · printed Nov 6, 2026

Cite this page

510(k) Report. “K061770: Ethicon Endo Surgery Endoscopic Suturing System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K061770

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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