510(k) · Cleared
ClearedNon-Shielded Surgical Trocar and Sleeve
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ethicon Endo-Surgery, Inc. · GCJ Laparoscope, General & Plastic Surgery
Cleared on Jan 8, 1997 after a 112-day review. The FDA summary names no predicate by number. 5 later devices descend from it.
- Decided
- Jan 8, 1997
- Review
- 112 days
- Class
- Class II
- Product code
- GCJ
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 2 citing it directly.
- This deviceK963760 Non-Shielded Surgical Trocar and SleeveEthicon Endo-Surgery, Inc. · 1997
- 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
- Descendant · 3 generations on · 0 of its ownK132629 Reprocessed Dilating Tip TrocarsStryker Sustainability Solutions · 2013
- Descendant · 3 generations on · 0 of its ownK100080 Reprocessed Trocars, Model B5LT and CB5LTAscent Healthcare Solutions · 2010 · Recalled
- Descendant · cites it directly · 0 of its ownK981527 Mentor Pathway Introducer/DilatorMentor Corp. · 1998
Most influential descendants
Showing 5 of 5 · 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
- K981527Mentor Pathway Introducer/DilatorMentor Corp. · 1998 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K963760 | Non-Shielded Surgical Trocar and Sleeve | Ethicon Endo-Surgery, Inc. | 1997 | — |
| +1 | K043253 | Vanguard Reprocessed Dilating Tip and Blunt Trocars | Vanguard Medical Concepts, Inc. | 2005 | 1 |
| +2 | K062497 | Reprocessed Trocars | Ascent Healthcare Solutions | 2007 | 2 |
| +3 | K132629 | Reprocessed Dilating Tip Trocars | Stryker Sustainability Solutions | 2013 | — |
| +3 | K100080 | Reprocessed Trocars, Model B5LT and CB5LT | Ascent Healthcare Solutions | 2010 | 1 |
| +1 | K981527 | Mentor Pathway Introducer/Dilator | Mentor Corp. | 1998 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2010 | 1 | 0 |
| 2013 | 1 | 0 |
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
What was it cleared against?
The FDA summary names no predicate by number.
What descends from it? (5)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 devicesGCJ Laparoscope, General & Plastic Surgery: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GCJ
21in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GCJ
108in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GCJ
5in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · GCJ
5,860in 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 (TRADE NAME) Non-shielded Surgical Trocar with Threaded Sleeve has application in thoracic, general, gynecologic, or other minimally invasive surgical procedures to establish a path of entry for minimally invasive instruments. The instrument is intended for insertion under direct visualization for secondary port locations.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K963760 · printed Nov 6, 2026
Cite this page
510(k) Report. “K963760: Non-Shielded Surgical Trocar and Sleeve.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K963760
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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