510(k) · Cleared
ClearedEndopath EP Disposable Trocar
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
ETHICON, Inc. · GCJ Laparoscope, General & Plastic Surgery
Cleared on Oct 12, 1993 after a 497-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 4 later devices descend from it.
- Decided
- Oct 12, 1993
- Review
- 497 days
- Class
- Class II
- Product code
- GCJ
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 3 citing it directly.
- This deviceK922608 Endopath EP Disposable TrocarETHICON, Inc. · 1993
- Descendant · cites it directly · 1 of its ownK043592 Reprocessed Endoscopic TrocarSterilmed, Inc. · 2005
- Descendant · cites it directly · 0 of its ownK060676 Nes Reprocessed Endoscopic TrocarNortheast Scientific, Inc. · 2007
- Descendant · 2 generations on · 0 of its ownK052299 Reprocessed Endoscopic TrocarSterilmed, Inc. · 2006
- Descendant · cites it directly · 0 of its ownK012578 Reprocessed Endoscopic TrocarSterilmed, Inc. · 2001
Most influential descendants
Showing 4 of 4 · See all- K043592Reprocessed Endoscopic TrocarSterilmed, Inc. · 2005 · cites it directly1descendant
- K060676Nes Reprocessed Endoscopic TrocarNortheast Scientific, Inc. · 2007 · cites it directly0descendants
- K052299Reprocessed Endoscopic TrocarSterilmed, Inc. · 2006 · 2 generations on0descendants
- K012578Reprocessed Endoscopic TrocarSterilmed, Inc. · 2001 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K922608 | Endopath EP Disposable Trocar | ETHICON, Inc. | 1993 | — |
| +1 | K043592 | Reprocessed Endoscopic Trocar | Sterilmed, Inc. | 2005 | — |
| +1 | K060676 | Nes Reprocessed Endoscopic Trocar | Northeast Scientific, Inc. | 2007 | — |
| +2 | K052299 | Reprocessed Endoscopic Trocar | Sterilmed, Inc. | 2006 | — |
| +1 | K012578 | Reprocessed Endoscopic Trocar | Sterilmed, Inc. | 2001 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
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
- #2 Held for the reportin the report
- #3 Held for the reportin the report
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? (4)
3 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, K043592 (Sterilmed, Inc., 2005) has gone furthest, with 1 descendant 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 | — |
https://510kreport.com/device/K922608 · printed Nov 6, 2026
Cite this page
510(k) Report. “K922608: Endopath EP Disposable Trocar.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K922608
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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