510(k) · Cleared
Recalled · Class II · 2013Versaport V2 Bladeless Optiical Trocar and/or Versaport Bladeless Optical Trocar
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Covidien, Formerly US Surgical A Divison of Tyco H · GCJ Laparoscope, General & Plastic Surgery
Cleared on Sep 1, 2011 as substantially equivalent to K100548 (Covidien Lp, Formerly Registered AS Tyco Healthcar, 2010) and 1 other predicate after a 16-day review. Its family tree reaches back 1 generation to 2001. 15 later devices descend from it. It has been recalled 6 times.
- Decided
- Sep 1, 2011
- Review
- 16 days
- Class
- Class II
- Product code
- GCJ
- Recalls
- 6
- Predicates
- 2
Its longest line of descent runs back 1 generation to K011257 (2001). 2 ancestors in all. 15 later devices descend from it, 5 citing it directly.
- Root · 1 generation backK011257 Endopath Non-Bladed Obturator Trocar System (5 MM)Ethicon Endo-Surgery, Inc. · 2001
- This deviceK112349 Versaport V2 Bladeless Optiical Trocar and/or Versaport Bladeless…Covidien, Formerly US Surgical A Divison of Tyco H · 2011
- Descendant · cites it directly · 11 of its ownK130435 Versaport V2 Bladeless Optical TrocarCovidien, Formerly US Surgical A Divison of Tyco H · 2013
- Descendant · 2 generations on · 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 · 3 generations on · 1 of its ownK162584 VersaOne Bladeless TrocarCovidien · 2016
Showing 5 of 15 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 15 · 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 · 2 generations on7descendants
- 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 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K011257 | Endopath Non-Bladed Obturator Trocar System (5 MM) | Ethicon Endo-Surgery, Inc. | 2001 | — |
| 0 (this device) | K112349 | Versaport V2 Bladeless Optiical Trocar and/or Versaport Bladeless Optical Trocar | Covidien, Formerly US Surgical A Divison of Tyco H | 2011 | — |
| +1 | 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 | — |
| +2 | K163654 | VersaOne fascial closure system bladed trocar, VersaOne fascial closure system… | Covidien, LLC | 2017 | — |
| +2 | K160564 | TroClose1200 | Gordian Surgical, Ltd. | 2016 | 1 |
| +3 | K162584 | VersaOne Bladeless Trocar | Covidien | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 5 | 0 |
| 2017 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 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 |
|---|---|---|---|
| * | K100548 | Versaport Bladeless Low Profile Trocar Model NB3SHFLP, NB5SHFLP, NB5STFLPSummary page 1…Surgical Trocar CLASSIFICATION NAME: Endloscope and Accessories PREDICATE DEVICE(S): Versaportl Bladeless Low ProfileTrocar [K1 00548] Endopath® Xcel h Trocar [K(01 1257) DEVICE DESCRIPTION: The Versap… | 2010 |
| * | K011257 | Endopath Non-Bladed Obturator Trocar System (5 MM)Summary page 2…of the VersaportN V2 Bladeless Optical 5mm trocar is substantially equivalent to the predicate device, EndlopathO Xcel trocar [K01 1257], To validate that the subject device performs as intended to facilitate… | 2001 |
What descends from it? (15)
See all 155 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K130435 | Versaport V2 Bladeless Optical Trocar | 2013 | 11 |
| K152149 | VersaOne Bladed Trocar 5mm | 2016 | 1 |
| K223593 | Inno-Port Disposable Bladeless Trocar, Inno-Port Disposable Optical Trocar | 2023 | 0 |
| K213818 | VersaOne Optical Trocar with Fixation Balloon Cannula, VersaOne Universal Fixation… | 2022 | 0 |
| K153258 | Medline ReNewal Reprocessed Versaport V2 Bladeless Optical Trocars | 2016 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 6, 2013 | Class II | Z-1469-2013 | Device Design | Seals may disengage from the cannula which may result in a component inadvertently disengaging into the patients cavity |
| May 6, 2013 | Class II | Z-1467-2013 | Device Design | Seals may disengage from the cannula which may result in a component inadvertently disengaging into the patients cavity |
| May 6, 2013 | Class II | Z-1472-2013 | Device Design | Seals may disengage from the cannula which may result in a component inadvertently disengaging into the patients cavity |
| May 6, 2013 | Class II | Z-1471-2013 | Device Design | Seals may disengage from the cannula which may result in a component inadvertently disengaging into the patients cavity |
| May 6, 2013 | Class II | Z-1470-2013 | Device Design | Seals may disengage from the cannula which may result in a component inadvertently disengaging into the patients cavity |
| May 6, 2013 | Class II | Z-1468-2013 | Device Design | Seals may disengage from the cannula which may result in a component inadvertently disengaging into the patients cavity |
The 5 latest of 6 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- None of the 2 ancestors has a recall.
- 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. 2011, 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 Versaport Bladeless Optical Trocar is 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K112349 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112349: Versaport V2 Bladeless Optiical Trocar and/or Versaport Bladeless Optical Trocar.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112349
Report an extraction error
Are you the manufacturer?
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