510(k) · Cleared
Recalled · Class II · 2023VersaOne Reusable Positioning Trocar System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Covidien · GCJ Laparoscope, General & Plastic Surgery
Cleared on Aug 26, 2020 as substantially equivalent to K130435 (Covidien, Formerly US Surgical A Divison of Tyco H, 2013) and 1 other predicate after a 56-day review. Its family tree reaches back 5 generations to 2001. It has been recalled 3 times.
- Decided
- Aug 26, 2020
- Review
- 56 days
- Class
- Class II
- Product code
- GCJ
- Recalls
- 3
- Predicates
- 2
Its longest line of descent runs back 5 generations to K011257 (2001). 8 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK011257 Endopath Non-Bladed Obturator Trocar System (5 MM)Ethicon Endo-Surgery, Inc. · 2001
- 4 generations backK112349 Versaport V2 Bladeless Optiical Trocar and/or Versaport Bladeless…Covidien, Formerly US Surgical A Divison of Tyco H · 2011 · Recalled
- 3 generations backK130435 Versaport V2 Bladeless Optical TrocarCovidien, Formerly US Surgical A Divison of Tyco H · 2013
- 2 generations backK151548 VersaOne Bladed Trocar, VersaOne Bladeless TrocarCovidien · 2015
- 1 generation backK162584 VersaOne Bladeless TrocarCovidien · 2016
- This deviceK201805 VersaOne Reusable Positioning Trocar SystemCovidien · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K011257 | Endopath Non-Bladed Obturator Trocar System (5 MM) | Ethicon Endo-Surgery, Inc. | 2001 | — |
| −4 | K112349 | Versaport V2 Bladeless Optiical Trocar and/or Versaport Bladeless Optical Trocar | Covidien, Formerly US Surgical A Divison of Tyco H | 2011 | 6 |
| −3 | K130435 | Versaport V2 Bladeless Optical Trocar | Covidien, Formerly US Surgical A Divison of Tyco H | 2013 | — |
| −2 | K151548 | VersaOne Bladed Trocar, VersaOne Bladeless Trocar | Covidien | 2015 | — |
| −1 | K162584 | VersaOne Bladeless Trocar | Covidien | 2016 | — |
| 0 (this device) | K201805 | VersaOne Reusable Positioning Trocar System | Covidien | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 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 |
|---|---|---|---|
| * | K130435 | Versaport V2 Bladeless Optical TrocarSummary page 4…assification Name Endoscope and Accessories Regulatory Class II Product Code GCJ Predicate Devices Primary K130435 – VersaportTM V2 Bladeless Optical Trocar Secondary K162584 – VersaOneTM Bladeless Trocar Reference Device… | 2013 |
| * | K162584 | VersaOne Bladeless TrocarSummary page 4…II Product Code GCJ Predicate Devices Primary K130435 – VersaportTM V2 Bladeless Optical Trocar Secondary K162584 – VersaOneTM Bladeless Trocar Reference Device K963115 – VersaportTM RT Trocar System Device Description The Versa… | 2016 |
| † | K963115 | Trocar Cannula | 1997 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 22, 2023 | Class II | Z-1464-2023 | Process control | There is a manufacturing non-conformance that may result in a metal shaving (burr) on the inside of the VersaOneTM Reusable Positioning Cannula, located where the Cannula and Body components are welded together. |
| Mar 22, 2023 | Class II | Z-1465-2023 | Process control | There is a manufacturing non-conformance that may result in a metal shaving (burr) on the inside of the VersaOneTM Reusable Positioning Cannula, located where the Cannula and Body components are welded together. |
| Mar 22, 2023 | Class II | Z-1463-2023 | Process control | There is a manufacturing non-conformance that may result in a metal shaving (burr) on the inside of the VersaOneTM Reusable Positioning Cannula, located where the Cannula and Body components are welded together. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 19 years and passes through 3 companies; a new generation was cleared every 2.3 years on median.
- 1 of the 8 ancestors has a recall of any class.
- 6 other devices also cite its predicate K130435.
How does its category compare?
All GCJ devicesGCJ Laparoscope, General & Plastic Surgery: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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 VersaOne™ reusable positioning trocar system is intended for use in a variety of gynecologic, general, thoracic and
urological endoscopic procedures to create and maintain a port of entry. The 11mm and 12 mm trocar may be used with or
without visualization for primary and secondary insertions.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K201805 · printed Nov 6, 2026
Cite this page
510(k) Report. “K201805: VersaOne Reusable Positioning 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/K201805
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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