510(k) Report

510(k) · Cleared

Cleared

Endopath Dilating Tip Trocar, Model #512XD

K020428510(k) SpecialCleared Mar 4, 200224-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 Mar 4, 2002 after a 24-day review. The FDA summary names its predicate without a number. 6 later devices descend from it.

Decided
Mar 4, 2002
Review
24 days
Class
Class II
Product code
GCJ
Recalls
None
Predicates
0

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

Descendants, by year cleared 2009: 1 descendant cleared2005: 2 descendants cleared2007: 1 descendant cleared2010: 1 descendant cleared2013: 1 descendant cleared200020052010201520202025
  1. This deviceK020428 Endopath Dilating Tip Trocar, Model #512XDEthicon Endo-Surgery, Inc. · 2002
  2. Descendant · cites it directly · 3 of its ownK043253 Vanguard Reprocessed Dilating Tip and Blunt TrocarsVanguard Medical Concepts, Inc. · 2005 · Recalled
  3. Descendant · 2 generations on · 2 of its ownK062497 Reprocessed TrocarsAscent Healthcare Solutions · 2007 · Recalled
  4. Descendant · 3 generations on · 0 of its ownK132629 Reprocessed Dilating Tip TrocarsStryker Sustainability Solutions · 2013
  5. Descendant · 3 generations on · 0 of its ownK100080 Reprocessed Trocars, Model B5LT and CB5LTAscent Healthcare Solutions · 2010 · Recalled
  6. Descendant · cites it directly · 0 of its ownK081398 Advanced Medical Innovations Disposable Trocars and Laparoscopic…Advanced Medical Innovations, Inc. · 2009

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2005: 22007: 12009: 12010: 12013: 1
2005high 2 (2005) · low 0 (2006)2026

Most influential descendants

Showing 5 of 6 · See all
  • K043253Vanguard Reprocessed Dilating Tip and Blunt TrocarsVanguard Medical Concepts, Inc. · 2005 · cites it directly3descendants
  • K062497Reprocessed TrocarsAscent Healthcare Solutions · 2007 · 2 generations on2descendants
  • K132629Reprocessed Dilating Tip TrocarsStryker Sustainability Solutions · 2013 · 3 generations on0descendants
  • K100080Reprocessed Trocars, Model B5LT and CB5LTAscent Healthcare Solutions · 2010 · 3 generations on0descendants
  • K081398Advanced Medical Innovations Disposable Trocars and Laparoscopic AccessoriesAdvanced Medical Innovations, Inc. · 2009 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K020428Endopath Dilating Tip Trocar, Model #512XDEthicon Endo-Surgery, Inc.2002—
+1K043253Vanguard Reprocessed Dilating Tip and Blunt TrocarsVanguard Medical Concepts, Inc.20051
+2K062497Reprocessed TrocarsAscent Healthcare Solutions20072
+3K132629Reprocessed Dilating Tip TrocarsStryker Sustainability Solutions2013—
+3K100080Reprocessed Trocars, Model B5LT and CB5LTAscent Healthcare Solutions20101
+1K081398Advanced Medical Innovations Disposable Trocars and Laparoscopic AccessoriesAdvanced Medical Innovations, Inc.2009—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200520
200710
200910
201010
201310
FIG. 1 — Lineage of K020428, 2002–2013Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K214046 780 nm 1688 4K Camera System, 780 nm L11 LED…score 21.4 · 21 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (2)

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.

TypeNumberDeviceApplicantDecidedRecalls
*—ENDOPATH® Dilating Tip Trocar
Named without a submission number
—
*—ENDOPATH® Non-Bladed Obturator and Sleeve
Named without a submission number
—

What descends from it? (6)

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

NumberDeviceApplicantDecidedDescendants
K043253Vanguard Reprocessed Dilating Tip and Blunt TrocarsVanguard Medical Concepts, Inc.20053
K081398Advanced Medical Innovations Disposable Trocars and Laparoscopic AccessoriesAdvanced Medical Innovations, Inc.20090
K033591Reprocessed TrocarsClearmedical, Inc.20050

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, K043253 (Vanguard Medical Concepts, Inc., 2005) has gone furthest, with 3 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

2007: 182008: 192009: 212010: 242011: 152012: 172013: 152014: 192015: 262016: 272017: 202018: 212019: 152020: 282021: 182022: 202023: 312024: 292025: 212026 (partial year): 26
2007high 31 (2023) · low 15 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GCJ

108in 2025

2007: 42 days median2008: 73 days median2009: 85 days median2010: 122 days median2011: 113 days median2012: 88 days median2013: 93 days median2014: 90 days median2015: 76 days median2016: 99 days median2017: 77 days median2018: 88 days median2019: 60 days median2020: 61 days median2021: 116 days median2022: 103 days median2023: 109 days median2024: 90 days median2025: 108 days median2026 (partial year): 122 days median
2007high 122 (2010) · low 42 (2007)2026

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

Recalls per year · GCJ

5in 2025

2007: 122008: 162009: 62010: 302011: 92012: 12013: 7, 1 Class I2014: 22016: 52017: 12018: 12022: 12023: 12025: 52026 (partial year): 1
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

2007: 1,6392008: 1,3192009: 1,9952010: 2,6572011: 2,1332012: 1,5262013: 1,5652014: 1,7142015: 1,7102016: 2,0802017: 3,4682018: 2,5622019: 2,5782020: 2,6182021: 3,4312022: 3,9452023: 6,0022024: 6,0472025: 5,860
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071842121,639
20081973161,319
2009218561,995
201024122302,657
20111511392,133
2012178811,526
201315937 (1)1,565
2014199021,714
2015267601,710
2016279952,080
2017207713,468
2018218812,562
2019156002,578
2020286102,618
20211811603,431
20222010313,945
20233110916,002
2024299006,047
20252110855,860
2026261221—

What is it indicated for?

The ENDOPATH® Dilating Tip Trocar has application in thoracic, gynecologic

laparoscopy, and other abdominal procedures to establish a path of entry for endoscopic

instruments.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

More from Ethicon Endo-Surgery, Inc.

111 FDA decisions under this applicant name. See the company

  • K141952Echelon Flex Powered Vascular Stapler with Advanced Placement Tip, Endopath Echelon Vascular White Reloads…Ethicon Endo-Surgery, Inc. · 20141 Class I recall
  • K111195Valutrus Reusable Circular Stapler and Disposable ReloadsEthicon Endo-Surgery, Inc. · 2011
  • K110385Echelon Flex 45 / 60 Powered Articulating Endoscopic Linear CutterEthicon Endo-Surgery, Inc. · 2011
  • K101520Enseal Tissue Sealing Devices Model: NSEAL514H-535H, NSEAL514RH-535RHEthicon Endo-Surgery, Inc. · 2010
  • K102632Ethicon Endo-Surgery 5MM Laparoscopic Multi-Feed StaplerEthicon Endo-Surgery, Inc. · 2010

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The GCJ category page

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https://510kreport.com/device/K020428 · printed Nov 6, 2026

Cite this page

510(k) Report. “K020428: Endopath Dilating Tip Trocar, Model #512XD.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K020428

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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