510(k) · Cleared
ClearedAutosuture Versaport Plus Bladless Trocar; Bladeless Trocar
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Covidien Lp, Formerly Registered AS United States · GCJ Laparoscope, General & Plastic Surgery
Cleared on May 23, 2008 after a 29-day review. The FDA summary names its predicate without a number. 14 later devices descend from it.
- Decided
- May 23, 2008
- Review
- 29 days
- Class
- Class II
- Product code
- GCJ
- Recalls
- None
- Predicates
- 0
14 later devices descend from it, 5 citing it directly.
- This deviceK081169 Autosuture Versaport Plus Bladless Trocar; Bladeless TrocarCovidien Lp, Formerly Registered AS United States · 2008
- Descendant · cites it directly · 11 of its ownK130435 Versaport V2 Bladeless Optical TrocarCovidien, Formerly US Surgical A Divison of Tyco H · 2013
- Descendant · cites it directly · 7 of its ownK151548 VersaOne Bladed Trocar, VersaOne Bladeless TrocarCovidien · 2015
- Descendant · 2 generations on · 1 of its ownK163654 VersaOne fascial closure system bladed trocar, VersaOne fascial…Covidien, LLC · 2017
- Descendant · 2 generations on · 1 of its ownK160564 TroClose1200Gordian Surgical, Ltd. · 2016 · Recalled
- Descendant · cites it directly · 1 of its ownK162584 VersaOne Bladeless TrocarCovidien · 2016
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K130435Versaport V2 Bladeless Optical TrocarCovidien, Formerly US Surgical A Divison of Tyco H · 2013 · cites it directly11descendants
- K151548VersaOne Bladed Trocar, VersaOne Bladeless TrocarCovidien · 2015 · cites it directly7descendants
- K163654VersaOne fascial closure system bladed trocar, VersaOne fascial closure system bladeless…Covidien, LLC · 2017 · 2 generations on1descendant
- K160564TroClose1200Gordian Surgical, Ltd. · 2016 · 2 generations on1descendant
- K162584VersaOne Bladeless TrocarCovidien · 2016 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K081169 | Autosuture Versaport Plus Bladless Trocar; Bladeless Trocar | Covidien Lp, Formerly Registered AS United States | 2008 | — |
| +1 | 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 | — |
| +2 | K163654 | VersaOne fascial closure system bladed trocar, VersaOne fascial closure system… | Covidien, LLC | 2017 | — |
| +2 | K160564 | TroClose1200 | Gordian Surgical, Ltd. | 2016 | 1 |
| +1 | K162584 | VersaOne Bladeless Trocar | Covidien | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 4 | 0 |
| 2017 | 1 | 0 |
| 2020 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 2 | 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 |
|---|---|---|---|
| * | — | autosuture VERSAPORT Named without a submission number | |
| * | — | Ethicon Excel Named without a submission number |
What descends from it? (14)
See all 145 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K130435 (Covidien, Formerly US Surgical A Divison of Tyco H, 2013) has gone furthest, with 11 descendants of its own.
How does its category compare?
All GCJ devicesGCJ Laparoscope, General & Plastic Surgery: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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 autosuture VERSAPORT PLUS Bladeless Trocar is 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/K081169 · printed Nov 6, 2026
Cite this page
510(k) Report. “K081169: Autosuture Versaport Plus Bladless Trocar; Bladeless Trocar.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K081169
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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