510(k) · Cleared
ClearedUnimicro Trocar Kit, models: Auto-Locking Trocar, Hasson Trocar, Bladeless Trocar
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Unimicro Medical Systems (Shenzhen) Co., Ltd. · GCJ Laparoscope, General & Plastic Surgery
Cleared on Aug 10, 2015 as substantially equivalent to K112358 (Unimax Medical Systems, Inc., 2011) after a 423-day review. Its family tree reaches back 2 generations to 1992. 5 later devices descend from it.
- Decided
- Aug 10, 2015
- Review
- 423 days
- Class
- Class II
- Product code
- GCJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K920110 (1992). 4 ancestors in all. 5 later devices descend from it, 4 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 deviceK141594 Unimicro Trocar Kit, models: Auto-Locking Trocar, Hasson Trocar…Unimicro Medical Systems (Shenzhen) Co., Ltd. · 2015
- Descendant · cites it directly · 1 of its ownK211148 CORE-TrocarIncore Co., Ltd. · 2022
- Descendant · cites it directly · 1 of its ownK172038 TrocarWickimed (Huizhou) Medical Equipment Manufacturing Co.,Ltd · 2017
- Descendant · cites it directly · 0 of its ownK241052 Bladeless Trocar; Bladed Trocar; Hasson TrocarAdvamedix, GmbH · 2024
- Descendant · 2 generations on · 0 of its ownK240196 Bladeless Trocar (E05, E10, E11, E12, ES05, ES10, ES12)Yuwonmeditech Co., Ltd. · 2024
- Descendant · cites it directly · 0 of its ownK232866 Disposable Abdominal Trocars (Bladed Trocars, Bladeless Trocars…Jiangsu Channel Medical Device Co., Ltd. · 2023
Most influential descendants
Showing 5 of 5 · See all- K211148CORE-TrocarIncore Co., Ltd. · 2022 · cites it directly1descendant
- K172038TrocarWickimed (Huizhou) Medical Equipment Manufacturing Co.,Ltd · 2017 · cites it directly1descendant
- K241052Bladeless Trocar; Bladed Trocar; Hasson TrocarAdvamedix, GmbH · 2024 · cites it directly0descendants
- K240196Bladeless Trocar (E05, E10, E11, E12, ES05, ES10, ES12)Yuwonmeditech Co., Ltd. · 2024 · 2 generations on0descendants
- K232866Disposable Abdominal Trocars (Bladed Trocars, Bladeless Trocars, Optical Trocars)Jiangsu Channel Medical Device Co., Ltd. · 2023 · cites it directly0descendants
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) | K141594 | Unimicro Trocar Kit, models: Auto-Locking Trocar, Hasson Trocar, Bladeless… | Unimicro Medical Systems (Shenzhen) Co., Ltd. | 2015 | — |
| +1 | K211148 | CORE-Trocar | Incore Co., Ltd. | 2022 | — |
| +1 | K172038 | Trocar | Wickimed (Huizhou) Medical Equipment Manufacturing Co.,Ltd | 2017 | — |
| +1 | K241052 | Bladeless Trocar; Bladed Trocar; Hasson Trocar | Advamedix, GmbH | 2024 | — |
| +2 | K240196 | Bladeless Trocar (E05, E10, E11, E12, ES05, ES10, ES12) | Yuwonmeditech Co., Ltd. | 2024 | — |
| +1 | K232866 | Disposable Abdominal Trocars (Bladed Trocars, Bladeless Trocars, Optical… | Jiangsu Channel Medical Device Co., Ltd. | 2023 | — |
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 |
|---|---|---|
| 2017 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 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 6…) Name and Code regulation number Unimax Disposable Unimax ClassⅡ, 21CFR K112358 Trocar Surgical Medical GCJ 876.1500 System Trocar Systems Inc.… | 2011 |
What descends from it? (5)
4 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?
- The line of descent spans 23 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, K211148 (Incore Co., Ltd., 2022) has gone furthest, with 1 descendant 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. 2015, 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 Unimicro Trocar kit,Model: Auto-Locking Trocar,Hasson Trocar, and Bladeless Trocar has application in a variety of endoscopic procedures to provide a port of entry for endoscopic instruments.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K141594 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141594: Unimicro Trocar Kit, models: Auto-Locking Trocar, Hasson Trocar, Bladeless Trocar.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141594
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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