510(k) · Cleared
ClearedXpan Universal Trocar System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Xpan, Inc. · GCJ Laparoscope, General & Plastic Surgery
Cleared on Jun 2, 2023 as substantially equivalent to K012539 (United States Surgical, A Division of Tyco Healthc, 2001) after a 186-day review. Its family tree reaches back 3 generations to 1994.
- Decided
- Jun 2, 2023
- Review
- 186 days
- Class
- Class II
- Product code
- GCJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K940232 (1994). 7 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK940232 Innerdyne Step Trocar Expandable Port, S.T.E.P.Innerdyne Medical, Inc. · 1994
- 2 generations backK961940 Innerdyne Step Trocar Expandable Port, OnestepInnerdyne, Inc. · 1996 · Recalled
- 1 generation backK012539 VerastepUnited States Surgical, A Division of Tyco Healthc · 2001
- This deviceK223562 Xpan Universal Trocar SystemXpan, Inc. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K940232 | Innerdyne Step Trocar Expandable Port, S.T.E.P. | Innerdyne Medical, Inc. | 1994 | — |
| −2 | K961940 | Innerdyne Step Trocar Expandable Port, Onestep | Innerdyne, Inc. | 1996 | 1 |
| −1 | K012539 | Verastep | United States Surgical, A Division of Tyco Healthc | 2001 | — |
| 0 (this device) | K223562 | Xpan Universal Trocar System | Xpan, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1995 | 3 | 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 |
|---|---|---|---|
| * | K012539 | VerastepSummary page 4…500 Review Panel General and Plastic Surgery Predicate Device: Proprietary/Trade VersaStep™ Bladeless Trocar Name 510(k) Number K012539 Common or Usual Name Surgical Trocar Classification Name Endoscope and Accessories Regulatory Class Cla… | 2001 |
| † | K982472 | Genicon Trocar | 1999 |
| † | K112349 | Versaport V2 Bladeless Optiical Trocar and/or Versaport Bladeless Optical Trocar | 2011 |
| † | K130435 | Versaport V2 Bladeless Optical Trocar | 2013 |
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 29 years and passes through 4 companies; a new generation was cleared every 5.2 years on median.
- 1 of the 7 ancestors has a recall of any class.
- 4 other devices also cite its predicate K012539.
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 Xpan Universal Trocar System is intended to provide dilation access with or without visualization to the abdominal and thoracic cavities for performing diagnostic and operative abdominal and thoracic procedures.
Laparoscopic access to the abdominal cavity, both primary and secondary punctures.
Thoracoscopic access to the thoracic cavity, both primary and secondary punctures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K223562 · printed Nov 6, 2026
Cite this page
510(k) Report. “K223562: Xpan Universal 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/K223562
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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