510(k) · Cleared

Cleared

Endopath Xcel Bladeless Trocar with Optiview Technology Endopath Xcel Blunt Tip Trocar with Optiview Technology Endopath

K122511510(k) TraditionalCleared Oct 1, 201245-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, LLC · GCJ Laparoscope, General & Plastic Surgery

Cleared on Oct 1, 2012 as substantially equivalent to K032676 (Ethicon Endo-Surgery, Inc., 2003) after a 45-day review. Its family tree reaches back 1 generation to 2003. 14 later devices descend from it.

Decided: Oct 1, 2012
Review: 45 days
Class: Class II
Product code: GCJ
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K032676 (2003). 14 later devices descend from it, 7 citing it directly.

By dateBy generation

Root · 1 generation backK032676 Endopath Bladeless Trocar, Endopath Blunt Tip Trocar, Endopath…Ethicon Endo-Surgery, Inc. · 2003 · Recalled
This deviceK122511 Endopath Xcel Bladeless Trocar with Optiview Technology Endopath…Ethicon Endo-Surgery, LLC · 2012
Descendant · cites it directly · 5 of its ownK190029 Disposable Bladeless Trocar, Disposable Optical Trocar, Disposable…Changzhou Xin Neng Yuan Medical Stapler Co.,Ltd · 2019
Descendant · 2 generations on · 1 of its ownK222695 troCarWash™ SystemBiotex, Inc. · 2023
Descendant · cites it directly · 1 of its ownK211250 VisionPort SystemNew View Surgical, Inc. · 2021
Descendant · cites it directly · 1 of its ownK162387 U-IGNITE Bladeless TrocarTianjin Uwell Medical Device Manufacturing Co., Ltd. · 2017
Descendant · 2 generations on · 0 of its ownK250820 Disposable TrocarsSinolinks Medical Innovation, Inc. · 2025

Showing 5 of 14 descendants. See all descendants

Descendants cleared per year

2013high 3 (2024) · low 0 (2014)2026

Most influential descendants

Showing 5 of 14 · See all

K190029Disposable Bladeless Trocar, Disposable Optical Trocar, Disposable Blunt-Tip Trocar…Changzhou Xin Neng Yuan Medical Stapler Co.,Ltd · 2019 · cites it directly5descendants
K222695troCarWash™ SystemBiotex, Inc. · 2023 · 2 generations on1descendant
K211250VisionPort SystemNew View Surgical, Inc. · 2021 · cites it directly1descendant
K162387U-IGNITE Bladeless TrocarTianjin Uwell Medical Device Manufacturing Co., Ltd. · 2017 · cites it directly1descendant
K250820Disposable TrocarsSinolinks Medical Innovation, Inc. · 2025 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K032676	Endopath Bladeless Trocar, Endopath Blunt Tip Trocar, Endopath Dilating Tip…	Ethicon Endo-Surgery, Inc.	2003	6
0 (this device)	K122511	Endopath Xcel Bladeless Trocar with Optiview Technology Endopath Xcel Blunt…	Ethicon Endo-Surgery, LLC	2012	—
+1	K190029	Disposable Bladeless Trocar, Disposable Optical Trocar, Disposable Blunt-Tip…	Changzhou Xin Neng Yuan Medical Stapler Co.,Ltd	2019	—
+2	K222695	troCarWash™ System	Biotex, Inc.	2023	—
+1	K211250	VisionPort System	New View Surgical, Inc.	2021	—
+1	K162387	U-IGNITE Bladeless Trocar	Tianjin Uwell Medical Device Manufacturing Co., Ltd.	2017	—
+2	K250820	Disposable Trocars	Sinolinks Medical Innovation, Inc.	2025	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2013	1	0
2016	1	0
2017	2	0
2019	1	0
2020	2	0
2021	1	0
2023	2	0
2024	3	0
2025	1	0

FIG. 1 — Lineage of K122511, 2003–2025Source: 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
*	K032676	Endopath Bladeless Trocar, Endopath Blunt Tip Trocar, Endopath Dilating Tip Trocar Summary page 1 …cope, General & Plastic Surgery Regulation Number 876.1500 Predicate Device ENDOPATFr"XCEL' 12mm Trocars, submitted as ENDOPATH Ill1Trocar System, K032676 Device Description: The ENDOPATH® XCEL® Trocars with OPT! VIEWTM Technology are sterile, single- patient use endoscopic devices u…	Ethicon Endo-Surgery, Inc.	2003	6

Also cleared against K032676: 25 other devices →

What descends from it? (14)

See all 14

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

Number	Device	Applicant	Decided	Descendants
K190029	Disposable Bladeless Trocar, Disposable Optical Trocar, Disposable Blunt-Tip Trocar…	Changzhou Xin Neng Yuan Medical Stapler Co.,Ltd	2019	5
K211250	VisionPort System	New View Surgical, Inc.	2021	1
K162387	U-IGNITE Bladeless Trocar	Tianjin Uwell Medical Device Manufacturing Co., Ltd.	2017	1
K201511	Reprocessed Endoscopic Trocars and Sleeves	Stryker Sustainability Solutions	2020	0
K172097	Reprocessed Ethicon Bladeless Trocars; Reprocessed Ethicon Universal Trocar Sleeves	Renovo, Inc.	2017	0
K160740	Medline ReNewal Reprocessed ENDOPATH XCEL Trocar with OPTIVIEW Technology	Surgical Instrument Service and Savings, Inc.	2016	0
K132629	Reprocessed Dilating Tip Trocars	Stryker Sustainability Solutions	2013	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 a recall.
Of its descendants, K190029 (Changzhou Xin Neng Yuan Medical Stapler Co.,Ltd, 2019) has gone furthest, with 5 descendants of its own.
25 other devices also cite its predicate K032676.

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. 2012, this device’s year, is highlighted.

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® XCEL® Bladeless Trocar has applications in abdominal, thoracic, and gynecologic minimally invasive surgical procedures to establish a path of entry for endoscopic instruments. The trocar may be used with or without visualization for primary and secondary insertions. The ENDOPATH® XCEL® Blunt Tip Trocar has application in thoracic, gynecologic, laparoscopic and other abdominal procedures to establish a path of entry for minimally invasive…

Read the full statement (117 words)

The ENDOPATH® XCEL® Blunt Tip Trocar has application in thoracic, gynecologic, laparoscopic and other abdominal procedures to establish a path of entry for minimally invasive instruments.

The ENDOPATH® XCEL® Dilating Tip Trocar has applications in thoracic, gynecologic laparoscopy and other abdominal procedures to establish a path of entry for endoscopic instruments.

The ENDOPATH ® XCEL® Universal Trocar Stability Sleeve has applications in thoracic, gynecologic laparoscopy and other abdominal procedures to establish a path of entry for endoscopic instruments.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K122511 · printed Nov 6, 2026

Cite this page

510(k) Report. “K122511: Endopath Xcel Bladeless Trocar with Optiview Technology Endopath Xcel Blunt Tip Trocar with Optiview Technology Endopath.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122511

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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