510(k) · Cleared
ClearedDisposable Endoscopic Trocar
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fengh Medical Co., Ltd. · GCJ Laparoscope, General & Plastic Surgery
Cleared on Apr 9, 2018 as substantially equivalent to K032676 (Ethicon Endo-Surgery, Inc., 2003) after a 75-day review. Its family tree reaches back 1 generation to 2003. 2 later devices descend from it.
- Decided
- Apr 9, 2018
- Review
- 75 days
- Class
- Class II
- Product code
- GCJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K032676 (2003). 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK032676 Endopath Bladeless Trocar, Endopath Blunt Tip Trocar, Endopath…Ethicon Endo-Surgery, Inc. · 2003 · Recalled
- This deviceK180208 Disposable Endoscopic TrocarFengh Medical Co., Ltd. · 2018
- Descendant · cites it directly · 1 of its ownK201641 Disposable Laparoscope TrocarBeijing Biosis Healing Biolog Ical Technology Co., Ltd. · 2020
- Descendant · cites it directly · 0 of its ownK232042 NexPort™ Trocar System (TS211001); NexPort™ Trocar System…Mediconcepts Technology (Shenzhen) Company Limited · 2023
Most influential descendants
Showing 2 of 2 · See all- K201641Disposable Laparoscope TrocarBeijing Biosis Healing Biolog Ical Technology Co., Ltd. · 2020 · cites it directly1descendant
- K232042NexPort™ Trocar System (TS211001); NexPort™ Trocar System (TS211002); NexPort™ Trocar…Mediconcepts Technology (Shenzhen) Company Limited · 2023 · cites it directly0descendants
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) | K180208 | Disposable Endoscopic Trocar | Fengh Medical Co., Ltd. | 2018 | — |
| +1 | K201641 | Disposable Laparoscope Trocar | Beijing Biosis Healing Biolog Ical Technology Co., Ltd. | 2020 | — |
| +1 | K232042 | NexPort™ Trocar System (TS211001); NexPort™ Trocar System (TS211002); NexPort™… | Mediconcepts Technology (Shenzhen) Company Limited | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2023 | 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? (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 | Decided |
|---|---|---|---|
| * | K032676 | Endopath Bladeless Trocar, Endopath Blunt Tip Trocar, Endopath Dilating Tip TrocarSummary page 4…GCJ Classification Name: General& Plastic Surgery Regulation Number: 21 CFR 876.1500 Classification: Class II FDA 510 (k) Number: K032676 SECTION 6 - 2 of 7 K1… | 2003 |
What descends from it? (2)
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?
How does its category compare?
All GCJ devicesGCJ Laparoscope, General & Plastic Surgery: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
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 Disposable Endoscopic 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.
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/K180208 · printed Nov 6, 2026
Cite this page
510(k) Report. “K180208: Disposable Endoscopic Trocar.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K180208
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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