510(k) · Cleared

Cleared

Endopath Non-Bladed Obturator Trocar System (5 MM)

K011257510(k) TraditionalCleared Jul 13, 200180-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 Jul 13, 2001 after an 80-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 22 later devices descend from it.

Decided: Jul 13, 2001
Review: 80 days
Class: Class II
Product code: GCJ
Recalls: None
Predicates: 0

22 later devices descend from it, 4 citing it directly.

This deviceK011257 Endopath Non-Bladed Obturator Trocar System (5 MM)Ethicon Endo-Surgery, Inc. · 2001
Descendant · cites it directly · 15 of its ownK112349 Versaport V2 Bladeless Optiical Trocar and/or Versaport Bladeless…Covidien, Formerly US Surgical A Divison of Tyco H · 2011 · Recalled
Descendant · 2 generations on · 11 of its ownK130435 Versaport V2 Bladeless Optical TrocarCovidien, Formerly US Surgical A Divison of Tyco H · 2013
Descendant · 3 generations on · 7 of its ownK151548 VersaOne Bladed Trocar, VersaOne Bladeless TrocarCovidien · 2015
Descendant · cites it directly · 3 of its ownK043253 Vanguard Reprocessed Dilating Tip and Blunt TrocarsVanguard Medical Concepts, Inc. · 2005 · Recalled
Descendant · 2 generations on · 2 of its ownK062497 Reprocessed TrocarsAscent Healthcare Solutions · 2007 · Recalled

Showing 5 of 22 descendants. See all descendants

Descendants cleared per year

2005high 5 (2016) · low 0 (2006)2026

Most influential descendants

Showing 5 of 22 · See all

K112349Versaport V2 Bladeless Optiical Trocar and/or Versaport Bladeless Optical TrocarCovidien, Formerly US Surgical A Divison of Tyco H · 2011 · cites it directly15descendants
K130435Versaport V2 Bladeless Optical TrocarCovidien, Formerly US Surgical A Divison of Tyco H · 2013 · 2 generations on11descendants
K151548VersaOne Bladed Trocar, VersaOne Bladeless TrocarCovidien · 2015 · 3 generations on7descendants
K043253Vanguard Reprocessed Dilating Tip and Blunt TrocarsVanguard Medical Concepts, Inc. · 2005 · cites it directly3descendants
K062497Reprocessed TrocarsAscent Healthcare Solutions · 2007 · 2 generations on2descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K011257	Endopath Non-Bladed Obturator Trocar System (5 MM)	Ethicon Endo-Surgery, Inc.	2001	—
+1	K112349	Versaport V2 Bladeless Optiical Trocar and/or Versaport Bladeless Optical Trocar	Covidien, Formerly US Surgical A Divison of Tyco H	2011	6
+2	K130435	Versaport V2 Bladeless Optical Trocar	Covidien, Formerly US Surgical A Divison of Tyco H	2013	—
+3	K151548	VersaOne Bladed Trocar, VersaOne Bladeless Trocar	Covidien	2015	—
+1	K043253	Vanguard Reprocessed Dilating Tip and Blunt Trocars	Vanguard Medical Concepts, Inc.	2005	1
+2	K062497	Reprocessed Trocars	Ascent Healthcare Solutions	2007	2

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2005	2	0
2007	2	0
2010	1	0
2011	1	0
2013	2	0
2014	1	0
2015	1	0
2016	5	0
2017	1	0
2020	1	0
2022	1	0
2023	1	0
2025	1	0
2026	2	0

FIG. 1 — Lineage of K011257, 2001–2026Source: 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
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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? (22)

See all 22

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

Number	Device	Applicant	Decided	Descendants
K112349	Versaport V2 Bladeless Optiical Trocar and/or Versaport Bladeless Optical Trocar	Covidien, Formerly US Surgical A Divison of Tyco H	2011	15
K043253	Vanguard Reprocessed Dilating Tip and Blunt Trocars	Vanguard Medical Concepts, Inc.	2005	3
K060676	Nes Reprocessed Endoscopic Trocar	Northeast Scientific, Inc.	2007	0
K033591	Reprocessed Trocars	Clearmedical, Inc.	2005	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, K112349 (Covidien, Formerly US Surgical A Divison of Tyco H, 2011) 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/K011257 · printed Nov 6, 2026

Cite this page

510(k) Report. “K011257: Endopath Non-Bladed Obturator Trocar System (5 MM).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K011257

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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