510(k) · Cleared
ClearedDisposable Abdominal Trocars (Bladed Trocars, Bladeless Trocars, Optical Trocars)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Jiangsu Channel Medical Device Co., Ltd. · GCJ Laparoscope, General & Plastic Surgery
Cleared on Nov 7, 2023 as substantially equivalent to K141594 (Unimicro Medical Systems (Shenzhen) Co., Ltd., 2015) and 1 other predicate after a 53-day review. Its family tree reaches back 4 generations to 1992.
- Decided
- Nov 7, 2023
- Review
- 53 days
- Class
- Class II
- Product code
- GCJ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K920110 (1992). 6 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK920110 Endopath Disposable Thoracic Trocar SleeveETHICON, Inc. · 1992
- 3 generations backK112358 Unimax Trocar SystemUnimax Medical Systems, Inc. · 2011
- 2 generations backK141594 Unimicro Trocar Kit, models: Auto-Locking Trocar, Hasson Trocar…Unimicro Medical Systems (Shenzhen) Co., Ltd. · 2015
- 1 generation backK172038 TrocarWickimed (Huizhou) Medical Equipment Manufacturing Co.,Ltd · 2017
- This deviceK232866 Disposable Abdominal Trocars (Bladed Trocars, Bladeless Trocars…Jiangsu Channel Medical Device Co., Ltd. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K920110 | Endopath Disposable Thoracic Trocar Sleeve | ETHICON, Inc. | 1992 | — |
| −3 | K112358 | Unimax Trocar System | Unimax Medical Systems, Inc. | 2011 | — |
| −2 | K141594 | Unimicro Trocar Kit, models: Auto-Locking Trocar, Hasson Trocar, Bladeless… | Unimicro Medical Systems (Shenzhen) Co., Ltd. | 2015 | — |
| −1 | K172038 | Trocar | Wickimed (Huizhou) Medical Equipment Manufacturing Co.,Ltd | 2017 | — |
| 0 (this device) | 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 |
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? (2)
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 |
|---|---|---|---|
| * | K141594 | Unimicro Trocar Kit, models: Auto-Locking Trocar, Hasson Trocar, Bladeless TrocarSummary page 5…scope, General & Plastic Surgery Classification: Class II Product code: GCJ Regulation Number: 876.1500 C. Predicate device: Primary Predicate Device: K141594 Product name: Unimicro Trocar kit Model: Auto-Locking Trocar, Hasson Trocar, Bladeless Trocar. Unimicro Medical Syste… | 2015 |
| * | K172038 | TrocarSummary page 5…: Unimicro Trocar kit Model: Auto-Locking Trocar, Hasson Trocar, Bladeless Trocar. Unimicro Medical Systems (ShenZhen) Co., Ltd. Secondary Predicate Device: K172038 Product name: Trocar, Model: Auto-Locking Trocar, Bladeless Trocar, Visible Trocar… | 2017 |
What descends from it?
No later submission names this one as a predicate yet.
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 31 years and passes through 5 companies; a new generation was cleared every 6.0 years on median.
- 1 of the 6 ancestors has a recall of any class.
- 3 other devices also cite its predicate K141594.
How does its category compare?
All GCJ devicesGCJ Laparoscope, General & Plastic Surgery: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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 Abdominal Trocars (Bladed Trocars, Bladeless Trocars, Optical Trocars) is used to puncture the abdominal wall of human body during laparoscopy and operation to establish the working channel for abdominal surgery.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K232866 · printed Nov 6, 2026
Cite this page
510(k) Report. “K232866: Disposable Abdominal Trocars (Bladed Trocars, Bladeless Trocars, Optical Trocars).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K232866
Report an extraction error
Are you the manufacturer?
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