510(k) · Cleared
ClearedVersaOne Optical Trocar 15mm, VersaOne Bladeless Trocar 15mm
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 Mar 1, 2016 as substantially equivalent to K130435 (Covidien, Formerly US Surgical A Divison of Tyco H, 2013) and 2 other predicates after a 29-day review. Its family tree reaches back 4 generations to 2001.
- Decided
- Mar 1, 2016
- Review
- 29 days
- Class
- Class II
- Product code
- GCJ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K011257 (2001). 7 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK011257 Endopath Non-Bladed Obturator Trocar System (5 MM)Ethicon Endo-Surgery, Inc. · 2001
- 3 generations backK112349 Versaport V2 Bladeless Optiical Trocar and/or Versaport Bladeless…Covidien, Formerly US Surgical A Divison of Tyco H · 2011 · Recalled
- 2 generations backK130435 Versaport V2 Bladeless Optical TrocarCovidien, Formerly US Surgical A Divison of Tyco H · 2013
- 1 generation backK151548 VersaOne Bladed Trocar, VersaOne Bladeless TrocarCovidien · 2015
- This deviceK160230 VersaOne Optical Trocar 15mm, VersaOne Bladeless Trocar 15mmCovidien · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K011257 | Endopath Non-Bladed Obturator Trocar System (5 MM) | Ethicon Endo-Surgery, Inc. | 2001 | — |
| −3 | K112349 | Versaport V2 Bladeless Optiical Trocar and/or Versaport Bladeless Optical Trocar | Covidien, Formerly US Surgical A Divison of Tyco H | 2011 | 6 |
| −2 | K130435 | Versaport V2 Bladeless Optical Trocar | Covidien, Formerly US Surgical A Divison of Tyco H | 2013 | — |
| −1 | K151548 | VersaOne Bladed Trocar, VersaOne Bladeless Trocar | Covidien | 2015 | — |
| 0 (this device) | K160230 | VersaOne Optical Trocar 15mm, VersaOne Bladeless Trocar 15mm | Covidien | 2016 | — |
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? (3)
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…Y NAME: VersaOne™ Bladeless Trocar 15mm COMMON/USUAL Surgical Trocar NAME: PREDICATE Versaport™ V2 Bladeless Optical (K130435) DEVICES: VersaOne™ Bladeless Trocar (K151548) Autosuture™ Versaport™ Pl… | 2013 |
| * | K151548 | VersaOne Bladed Trocar, VersaOne Bladeless TrocarSummary page 4…UAL Surgical Trocar NAME: PREDICATE Versaport™ V2 Bladeless Optical (K130435) DEVICES: VersaOne™ Bladeless Trocar (K151548) Autosuture™ Versaport™ Plus Bladeless Trocar (K081169)… | 2015 |
| * | K081169 | Autosuture Versaport Plus Bladless Trocar; Bladeless TrocarSummary page 4…ss Optical (K130435) DEVICES: VersaOne™ Bladeless Trocar (K151548) Autosuture™ Versaport™ Plus Bladeless Trocar (K081169) Page 1 of 3… | 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 15 years and passes through 3 companies; a new generation was cleared every 2.3 years on median.
- 1 of the 7 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. 2016, 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™ optical trocars are intended for use in a variety of gynecologic, general, thoracic and urologic endoscopic procedures to create and maintain a port of entry. The trocar may be used with or without visualization for primary and secondary insertions.
The VersaOne™ bladeless trocars are intended for use in a variety of gynecologic, general, thoracic and urologic endoscopic procedures to create and maintain a port of entry.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K160230 · printed Nov 4, 2026
Cite this page
510(k) Report. “K160230: VersaOne Optical Trocar 15mm, VersaOne Bladeless Trocar 15mm.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K160230
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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