510(k) · Cleared

Cleared

Ethicon Endo Surgery Articulating Needle Knife, Model 2504

K073046510(k) TraditionalCleared Feb 25, 2008119-day reviewClass II21 CFR 878.4400

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. · GEI Electrosurgical, Cutting & Coagulation & Accessories

Cleared on Feb 25, 2008 as substantially equivalent to K972497 (KARL STORZ Endoscopy-America, Inc., 1997) and 2 other predicates after a 119-day review. Its family tree reaches back 1 generation to 1997. 6 later devices descend from it.

Decided: Feb 25, 2008
Review: 119 days
Class: Class II
Product code: GEI
Recalls: None
Predicates: 3

Its longest line of descent runs back 1 generation to K970053 (1997). 3 ancestors in all. 6 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 1 generation backK970053 UltratomerxBoston Scientific Corp · 1997
This deviceK073046 Ethicon Endo Surgery Articulating Needle Knife, Model 2504Ethicon Endo-Surgery, Inc. · 2008
Descendant · cites it directly · 2 of its ownK082955 Ethicon Endo-Surgery Articulating Hook Knife, Model IN4505Ethicon Endo-Surgery, Inc. · 2009
Descendant · cites it directly · 2 of its ownK082114 Electrocautery Dilation Balloon, Models: Edb-0018-00, Edb-0020-00…Apollo Endosurgery, Inc. · 2008
Descendant · 2 generations on · 0 of its ownK103155 Sumo Access and Tissue Resection SystemApollo Endosurgery, Inc. · 2011
Descendant · 2 generations on · 0 of its ownK093279 Navix Access DeviceXlumena · 2010 · Recalled
Descendant · 2 generations on · 0 of its ownK091824 Ethicon Endo-Surgery Rotating Endoscopic Scissors, Model IN2507Ethicon Endo-Surgery, Inc. · 2009

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2008high 3 (2009) · low 0 (2012)2026

Most influential descendants

Showing 5 of 6 · See all

K082955Ethicon Endo-Surgery Articulating Hook Knife, Model IN4505Ethicon Endo-Surgery, Inc. · 2009 · cites it directly2descendants
K082114Electrocautery Dilation Balloon, Models: Edb-0018-00, Edb-0020-00, Edb-0022-00Apollo Endosurgery, Inc. · 2008 · cites it directly2descendants
K103155Sumo Access and Tissue Resection SystemApollo Endosurgery, Inc. · 2011 · 2 generations on0descendants
K093279Navix Access DeviceXlumena · 2010 · 2 generations on0descendants
K091824Ethicon Endo-Surgery Rotating Endoscopic Scissors, Model IN2507Ethicon Endo-Surgery, Inc. · 2009 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K970053	Ultratomerx	Boston Scientific Corp	1997	—
0 (this device)	K073046	Ethicon Endo Surgery Articulating Needle Knife, Model 2504	Ethicon Endo-Surgery, Inc.	2008	—
+1	K082955	Ethicon Endo-Surgery Articulating Hook Knife, Model IN4505	Ethicon Endo-Surgery, Inc.	2009	—
+1	K082114	Electrocautery Dilation Balloon, Models: Edb-0018-00, Edb-0020-00, Edb-0022-00	Apollo Endosurgery, Inc.	2008	—
+2	K103155	Sumo Access and Tissue Resection System	Apollo Endosurgery, Inc.	2011	—
+2	K093279	Navix Access Device	Xlumena	2010	1
+2	K091824	Ethicon Endo-Surgery Rotating Endoscopic Scissors, Model IN2507	Ethicon Endo-Surgery, Inc.	2009	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1997	1	0
2000	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2008	1	0
2009	3	0
2010	1	0
2011	1	0

FIG. 1 — Lineage of K073046, 1997–2011Source: 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 GEI? 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 GEI device

#1 K231790 The InMode System with the Morpheus8 Applicatorsscore 32.7 · 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? (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
*	K972497	Karl Storz Monopolar Coagulating Electrodes/ Karl Storz Monopolar Coagulating Needle… Summary page 1 …ical cutting and coagulation device and accessories (21 CFR 878.4400, Product Code GET) Predicate Devices KSEA Monopolar Coagulating Needle Electrode (K972497) Colorado MicroDissection Needle (K000348) Boston Scientific RX Needle Knife (K970053)…	KARL STORZ Endoscopy-America, Inc.	1997	—
*	K000348	Colorado Microdissection Needle Summary page 1 …ries (21 CFR 878.4400, Product Code GET) Predicate Devices KSEA Monopolar Coagulating Needle Electrode (K972497) Colorado MicroDissection Needle (K000348) Boston Scientific RX Needle Knife (K970053) Device Description The Ethicon Endo Surgery® (FES) Articulatin…	Stryker Leibinger	2000	—
*	K970053	Ultratomerx Summary page 1 …A Monopolar Coagulating Needle Electrode (K972497) Colorado MicroDissection Needle (K000348) Boston Scientific RX Needle Knife (K970053) Device Description The Ethicon Endo Surgery® (FES) Articulating Needle Knife is an endoscopic instrument intended for cutting,…	Boston Scientific Corp	1997	—

What descends from it? (6)

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

Number	Device	Applicant	Decided	Descendants
K082955	Ethicon Endo-Surgery Articulating Hook Knife, Model IN4505	Ethicon Endo-Surgery, Inc.	2009	2
K082114	Electrocautery Dilation Balloon, Models: Edb-0018-00, Edb-0020-00, Edb-0022-00	Apollo Endosurgery, Inc.	2008	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?

None of the 3 ancestors has a recall.
Of its descendants, K082955 (Ethicon Endo-Surgery, Inc., 2009) has gone furthest, with 2 descendants of its own.

How does its category compare?

All GEI devices

GEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.

FDA decisions per year · GEI

52in 2025

2007high 65 (2023) · low 35 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GEI

113in 2025

2007high 183 (2026) · low 51 (2007)2026

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

Recalls per year · GEI

4in 2025

2007high 51 (2010) · low 1 (2020)2026

Class I (14 since 2007) Class II/III not classified

Adverse event reports per year · GEI

7,592in 2025

2007high 7,897 (2024) · low 2,556 (2008)2025

MAUDE reports naming product code GEI, 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	50	51	21	2,795
2008	61	71	19	2,556
2009	42	130	27	3,591
2010	46	109	51	3,377
2011	35	135	32	4,463
2012	39	133	30	5,216
2013	48	136	13	4,897
2014	49	103	3	4,908
2015	47	123	4	4,936
2016	64	108	3	5,616
2017	52	72	2	6,073
2018	47	93	6	6,545
2019	48	93	5	7,067
2020	59	105	1	6,490
2021	46	146	6	6,354
2022	55	150	49	6,103
2023	65	104	27 (4)	7,176
2024	59	125	22 (10)	7,897
2025	52	113	4	7,592
2026	43	183	8	—

What is it indicated for?

The Articulating Needle Knife is a monopolar electrosurgical instrument intended for cutting, dissecting and cauterizing soft tissue during endoscopic electrosurgical procedures. The Articulating Needle Knife is not intended for use in the central nervous system or in the central circulatory system.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K073046 · printed Nov 4, 2026

Cite this page

510(k) Report. “K073046: Ethicon Endo Surgery Articulating Needle Knife, Model 2504.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K073046

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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