510(k) · Cleared
ClearedUnimax Trocar System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Unimax Medical Systems, Inc. · GCJ Laparoscope, General & Plastic Surgery
Cleared on Oct 17, 2011 as substantially equivalent to K032676 (Ethicon Endo-Surgery, Inc., 2003) and 2 other predicates after a 62-day review. Its family tree reaches back 1 generation to 1992. 16 later devices descend from it.
- Decided
- Oct 17, 2011
- Review
- 62 days
- Class
- Class II
- Product code
- GCJ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K920110 (1992). 3 ancestors in all. 16 later devices descend from it, 6 citing it directly.
- Root · 1 generation backK920110 Endopath Disposable Thoracic Trocar SleeveETHICON, Inc. · 1992
- This deviceK112358 Unimax Trocar SystemUnimax Medical Systems, Inc. · 2011
- Descendant · cites it directly · 6 of its ownK133845 8MM Trocar KitIntuitive Surgical · 2014 · Recalled
- Descendant · cites it directly · 5 of its ownK141594 Unimicro Trocar Kit, models: Auto-Locking Trocar, Hasson Trocar…Unimicro Medical Systems (Shenzhen) Co., Ltd. · 2015
- Descendant · 2 generations on · 4 of its ownK181395 Universal Cannula Seal (5-12 mm)Intuitive Surgical, Inc. · 2018
- Descendant · 3 generations on · 3 of its ownK231358 Universal Seal (5-12 mm)Intuitive Surgical, Inc. · 2023
- Descendant · 4 generations on · 2 of its ownK241360 Universal Seal (5-12 mm)Intuitive Surgical, Inc. · 2024
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 16 · See all- K1338458MM Trocar KitIntuitive Surgical · 2014 · cites it directly6descendants
- K141594Unimicro Trocar Kit, models: Auto-Locking Trocar, Hasson Trocar, Bladeless TrocarUnimicro Medical Systems (Shenzhen) Co., Ltd. · 2015 · cites it directly5descendants
- K181395Universal Cannula Seal (5-12 mm)Intuitive Surgical, Inc. · 2018 · 2 generations on4descendants
- K231358Universal Seal (5-12 mm)Intuitive Surgical, Inc. · 2023 · 3 generations on3descendants
- K241360Universal Seal (5-12 mm)Intuitive Surgical, Inc. · 2024 · 4 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K920110 | Endopath Disposable Thoracic Trocar Sleeve | ETHICON, Inc. | 1992 | — |
| 0 (this device) | K112358 | Unimax Trocar System | Unimax Medical Systems, Inc. | 2011 | — |
| +1 | K133845 | 8MM Trocar Kit | Intuitive Surgical | 2014 | 2 |
| +1 | K141594 | Unimicro Trocar Kit, models: Auto-Locking Trocar, Hasson Trocar, Bladeless… | Unimicro Medical Systems (Shenzhen) Co., Ltd. | 2015 | — |
| +2 | K181395 | Universal Cannula Seal (5-12 mm) | Intuitive Surgical, Inc. | 2018 | — |
| +3 | K231358 | Universal Seal (5-12 mm) | Intuitive Surgical, Inc. | 2023 | — |
| +4 | K241360 | Universal Seal (5-12 mm) | Intuitive Surgical, Inc. | 2024 | — |
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 |
|---|---|---|
| 2014 | 2 | 0 |
| 2015 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 4 | 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? (3)
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 2…evice Name: ENDOPATH Bladeless Trocar, ENDOPATH Blunt Tip Trocar, ENDOPATH Dilating Tip Trocar Manufacturer: ETHICON ENDO-SURGERY, INC. Product Code: GCJ 510(k) Number: K032676 Predicate Device Name: Shielded Surgical Trocar Manufacturer: ETHICON ENDO-SURGERY, lNd. Product Code: . GClJ 510(k) Number: K971… | 2003 |
| * | K971475 | Shielded Surgical TrocarSummary page 2…NC. Product Code: GCJ 510(k) Number: K032676 Predicate Device Name: Shielded Surgical Trocar Manufacturer: ETHICON ENDO-SURGERY, lNd. Product Code: . GClJ 510(k) Number: K971475 Predicate Device Name: ENDOPATH Disposable Thoracic Trocar Sleeve Manufacturer: ETHICON ENDO-SURGERY, INC. Product Code: GEA/GC)… | 1997 |
| * | K920110 | Endopath Disposable Thoracic Trocar SleeveSummary page 2…J 510(k) Number: K971475 Predicate Device Name: ENDOPATH Disposable Thoracic Trocar Sleeve Manufacturer: ETHICON ENDO-SURGERY, INC. Product Code: GEA/GC) 5§10(k) Number: K920110 5.7 Intended Use and [ndications for Use of the subject device. The Unimax Trocar System, Model: Auto-Locking Trocar, Biadeless… | 1992 |
What descends from it? (16)
See all 166 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. 2011, 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 Unimax Trocar System, Model: Auto-Locking Trocar, Bladeless Trocar, Visible Trocar, Hasson Trocar, Dilating Trocar, Secondary Trocer, and Thoracic Trocar has application in a variety of endoscopic procedures to provide a port of entry for cndoscobic 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/K112358 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112358: Unimax Trocar System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112358
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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