510(k) · Cleared
ClearedDisposable Trocars
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hangzhou Kangji Medical Instrument Co., Ltd. · GCJ Laparoscope, General & Plastic Surgery
Cleared on Apr 9, 2024 as substantially equivalent to K112358 (Unimax Medical Systems, Inc., 2011) and 4 other predicates after a 193-day review. Its family tree reaches back 7 generations to 1994.
- Decided
- Apr 9, 2024
- Review
- 193 days
- Class
- Class II
- Product code
- GCJ
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 7 generations to K940232 (1994). 41 ancestors in all, the oldest K883018 (1988). No later device cites it as a predicate yet.
- Root · 7 generations backK940232 Innerdyne Step Trocar Expandable Port, S.T.E.P.Innerdyne Medical, Inc. · 1994
- 6 generations backK961940 Innerdyne Step Trocar Expandable Port, OnestepInnerdyne, Inc. · 1996 · Recalled
- 5 generations backK012539 VerastepUnited States Surgical, A Division of Tyco Healthc · 2001
- 4 generations backK072814 Convenience Kit for Single-Incision Laparoscopic Surgery and Other…Covidien · 2008
- 3 generations backK082619 Sils Port, Models SILSPT5, SILSPT12Covidien Lp, Formerly Registered AS United States · 2008
- 2 generations backK093372 Sils Port Model SILSPT15Covidien Lp, Formerly Registered AS Tyco Healthcar · 2009
- 1 generation backK141715 Glove PortNelis · 2015
- This deviceK233263 Disposable TrocarsHangzhou Kangji Medical Instrument Co., Ltd. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K940232 | Innerdyne Step Trocar Expandable Port, S.T.E.P. | Innerdyne Medical, Inc. | 1994 | — |
| −6 | K961940 | Innerdyne Step Trocar Expandable Port, Onestep | Innerdyne, Inc. | 1996 | 1 |
| −5 | K012539 | Verastep | United States Surgical, A Division of Tyco Healthc | 2001 | — |
| −4 | K072814 | Convenience Kit for Single-Incision Laparoscopic Surgery and Other Advanced… | Covidien | 2008 | — |
| −3 | K082619 | Sils Port, Models SILSPT5, SILSPT12 | Covidien Lp, Formerly Registered AS United States | 2008 | — |
| −2 | K093372 | Sils Port Model SILSPT15 | Covidien Lp, Formerly Registered AS Tyco Healthcar | 2009 | — |
| −1 | K141715 | Glove Port | Nelis | 2015 | — |
| 0 (this device) | K233263 | Disposable Trocars | Hangzhou Kangji Medical Instrument Co., Ltd. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 3 | 0 |
| 1993 | 3 | 0 |
| 1994 | 3 | 0 |
| 1995 | 4 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2006 | 3 | 0 |
| 2007 | 2 | 0 |
| 2008 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2021 | 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? (5)
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…Model of proposed Predicate device Manufacturer 510(k) No. device Unimax Medical K112358 Unimax Trocar System GCJ Systems I… | 2011 |
| * | K211577 | SoftFix Balloon TrocarSummary page 6…GCJ Systems Inc. Unimax Medical K211577 SoftFixTM Balloon Trocar GCJ Systems I… | 2021 |
| * | K141715 | Glove PortSummary page 6…Unimax Medical K211577 SoftFixTM Balloon Trocar GCJ Systems Inc. K141715 Glove Port NELIS OTJ K093372 SILS™ Port COVIDIEN… | 2015 |
| * | K093372 | Sils Port Model SILSPT15Summary page 6…GCJ Systems Inc. K141715 Glove Port NELIS OTJ K093372 SILS™ Port COVIDIEN LP GCJ ASC TriPort Laparoscopic Advanced S… | 2009 |
| * | K073719 | Asc Triport Laparoscopic Access DeviceSummary page 6…OTJ K093372 SILS™ Port COVIDIEN LP GCJ ASC TriPort Laparoscopic Advanced Surgical K073719 GCJ Access Device Concepts.… | 2008 |
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 30 years and passes through 8 companies; a new generation was cleared every 5.2 years on median.
- 7 of the 41 ancestors have a recall of any class.
- 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. 2024, 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 Trocars have application in a variety of endoscopic procedures to provide a port of entry for endoscopic instruments and/or endoscope.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K233263 · printed Nov 6, 2026
Cite this page
510(k) Report. “K233263: Disposable Trocars.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K233263
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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