510(k) · Cleared

Cleared

Endopath Disposable Endoscopic Multifeed Stapler

K913469510(k) TraditionalCleared Sep 30, 199156-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, Inc. · GCJ Laparoscope, General & Plastic Surgery

Cleared on Sep 30, 1991 after a 56-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 25 later devices descend from it.

Decided: Sep 30, 1991
Review: 56 days
Class: Class II
Product code: GCJ
Recalls: None
Predicates: 0

25 later devices descend from it, 3 citing it directly.

This deviceK913469 Endopath Disposable Endoscopic Multifeed StaplerETHICON, Inc. · 1991
Descendant · cites it directly · 15 of its ownK032093 PariefixSofradim Production · 2003
Descendant · 2 generations on · 14 of its ownK060494 Easytac Anchor. Easytac Delivery SystemMedchannel, LLC · 2006
Descendant · 3 generations on · 13 of its ownK082396 Davol Absorbable Fastener System, Model (S) 0113080,0113081…C.R. Bard, Inc. · 2009
Descendant · cites it directly · 7 of its ownK013749 Endoanchor and OpenanchorEthicon Endo-Surgery, Inc. · 2002
Descendant · 4 generations on · 6 of its ownK092483 Bard Permafix Fixation System, Model 0113012, 0113014, 0113016…C.R. Bard, Inc. · 2009

Showing 5 of 25 descendants. See all descendants

Descendants cleared per year

2002high 4 (2010) · low 0 (2004)2026

Most influential descendants

Showing 5 of 25 · See all

K032093PariefixSofradim Production · 2003 · cites it directly15descendants
K060494Easytac Anchor. Easytac Delivery SystemMedchannel, LLC · 2006 · 2 generations on14descendants
K082396Davol Absorbable Fastener System, Model (S) 0113080,0113081, 0113082, 0113084, 0113086…C.R. Bard, Inc. · 2009 · 3 generations on13descendants
K013749Endoanchor and OpenanchorEthicon Endo-Surgery, Inc. · 2002 · cites it directly7descendants
K092483Bard Permafix Fixation System, Model 0113012, 0113014, 0113016, 0116018C.R. Bard, Inc. · 2009 · 4 generations on6descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K913469	Endopath Disposable Endoscopic Multifeed Stapler	ETHICON, Inc.	1991	—
+1	K032093	Pariefix	Sofradim Production	2003	—
+2	K060494	Easytac Anchor. Easytac Delivery System	Medchannel, LLC	2006	—
+3	K082396	Davol Absorbable Fastener System, Model (S) 0113080,0113081, 0113082, 0113084…	C.R. Bard, Inc.	2009	—
+1	K013749	Endoanchor and Openanchor	Ethicon Endo-Surgery, Inc.	2002	—
+4	K092483	Bard Permafix Fixation System, Model 0113012, 0113014, 0113016, 0116018	C.R. Bard, Inc.	2009	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2002	2	0
2003	1	0
2006	2	0
2009	3	0
2010	4	0
2011	2	0
2013	2	0
2014	1	0
2015	1	0
2016	1	0
2017	2	0
2019	2	0
2021	2	0

FIG. 1 — Lineage of K913469, 1991–2021Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (25)

See all 25

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

Number	Device	Applicant	Decided	Descendants
K032093	Pariefix	Sofradim Production	2003	15
K013749	Endoanchor and Openanchor	Ethicon Endo-Surgery, Inc.	2002	7
K102632	Ethicon Endo-Surgery 5MM Laparoscopic Multi-Feed Stapler	Ethicon Endo-Surgery, Inc.	2010	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?

Of its descendants, K032093 (Sofradim Production, 2003) has gone furthest, with 15 descendants of its own.

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	—

https://510kreport.com/device/K913469 · printed Nov 6, 2026

Cite this page

510(k) Report. “K913469: Endopath Disposable Endoscopic Multifeed Stapler.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K913469

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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