510(k) · Cleared
Recalled · Class II · 20168MM Trocar Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Intuitive Surgical · GCJ Laparoscope, General & Plastic Surgery
Cleared on Feb 19, 2014 as substantially equivalent to K112358 (Unimax Medical Systems, Inc., 2011) after a 63-day review. Its family tree reaches back 2 generations to 1992. 6 later devices descend from it. It has been recalled 2 times.
- Decided
- Feb 19, 2014
- Review
- 63 days
- Class
- Class II
- Product code
- GCJ
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 2 generations to K920110 (1992). 4 ancestors in all. 6 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK920110 Endopath Disposable Thoracic Trocar SleeveETHICON, Inc. · 1992
- 1 generation backK112358 Unimax Trocar SystemUnimax Medical Systems, Inc. · 2011
- This deviceK133845 8MM Trocar KitIntuitive Surgical · 2014
- Descendant · cites it directly · 4 of its ownK181395 Universal Cannula Seal (5-12 mm)Intuitive Surgical, Inc. · 2018
- Descendant · 2 generations on · 3 of its ownK231358 Universal Seal (5-12 mm)Intuitive Surgical, Inc. · 2023
- Descendant · 3 generations on · 2 of its ownK241360 Universal Seal (5-12 mm)Intuitive Surgical, Inc. · 2024
- Descendant · 4 generations on · 1 of its ownK253978 Universal Seal (5-12 mm)Intuitive Surgical, Inc. · 2026
- Descendant · 5 generations on · 0 of its ownK261249 Universal Seal (5-12 mm)Intuitive Surgical, Inc. · 2026
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K181395Universal Cannula Seal (5-12 mm)Intuitive Surgical, Inc. · 2018 · cites it directly4descendants
- K231358Universal Seal (5-12 mm)Intuitive Surgical, Inc. · 2023 · 2 generations on3descendants
- K241360Universal Seal (5-12 mm)Intuitive Surgical, Inc. · 2024 · 3 generations on2descendants
- K253978Universal Seal (5-12 mm)Intuitive Surgical, Inc. · 2026 · 4 generations on1descendant
- K261249Universal Seal (5-12 mm)Intuitive Surgical, Inc. · 2026 · 5 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K920110 | Endopath Disposable Thoracic Trocar Sleeve | ETHICON, Inc. | 1992 | — |
| −1 | K112358 | Unimax Trocar System | Unimax Medical Systems, Inc. | 2011 | — |
| 0 (this device) | K133845 | 8MM Trocar Kit | Intuitive Surgical | 2014 | — |
| +1 | K181395 | Universal Cannula Seal (5-12 mm) | Intuitive Surgical, Inc. | 2018 | — |
| +2 | K231358 | Universal Seal (5-12 mm) | Intuitive Surgical, Inc. | 2023 | — |
| +3 | K241360 | Universal Seal (5-12 mm) | Intuitive Surgical, Inc. | 2024 | — |
| +4 | K253978 | Universal Seal (5-12 mm) | Intuitive Surgical, Inc. | 2026 | — |
| +5 | K261249 | Universal Seal (5-12 mm) | Intuitive Surgical, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2018 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2026 | 2 | 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 |
|---|---|---|---|
| * | K112358 | Unimax Trocar SystemSummary page 4…8 mm Trocar Disposable Surgical Trocar/Cannula Class 11 21 CFR 876.1500, Laparoscope, General & Plastic Surgery GQa General and Plastic Surgery Unimax Trocar System (K112358) The 8 mm Trocar consists of a cannula, an obturator, and a universal cannula seal. It provides a port of entry for endoscopic i… | 2011 |
What descends from it? (6)
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 10, 2016 | Class II | Z-2038-2016 | Unknown/Undetermined by firm | Cell Marque became aware of some lots of SIOOA I (EP I84) Rabbit Monoclonal Antibody, catalogue numbers 408R-14, 408R-15, and 408R-16, that exhibited an unacceptable IHC test result. |
| May 9, 2016 | Class II | Z-1836-2016 | Manufacturing material removal | Potential for particulates in insufflation stopcocks on the da Vinci Xi Surgical System cannula seals. The particulates could be introduced into the cannula lumen when insufflation is connected during a surgical procedure. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 22 years and passes through 3 companies; a new generation was cleared every 19.5 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K181395 (Intuitive Surgical, Inc., 2018) has gone furthest, with 4 descendants of its own.
- 5 other devices also cite its predicate K112358.
How does its category compare?
All GCJ devicesGCJ Laparoscope, General & Plastic Surgery: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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 8 mm Trocar has application in a variety of endoscopic procedures to provide a port 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.
https://510kreport.com/device/K133845 · printed Nov 5, 2026
Cite this page
510(k) Report. “K133845: 8MM Trocar Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K133845
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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