510(k) · Cleared
ClearedMedline ReNewal Reprocessed Versaport V2 Bladeless Optical Trocars
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Surgical Instrument Service and Savings (Dba Medline Renewal · NLM Laparoscope, General & Plastic Surgery, Reprocessed
Cleared on Apr 5, 2016 as substantially equivalent to K112349 (Covidien, Formerly US Surgical A Divison of Tyco H, 2011) after a 147-day review. Its family tree reaches back 2 generations to 2001.
- Decided
- Apr 5, 2016
- Review
- 147 days
- Class
- Class II
- Product code
- NLM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K011257 (2001). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 2 generations backK011257 Endopath Non-Bladed Obturator Trocar System (5 MM)Ethicon Endo-Surgery, Inc. · 2001
- 1 generation backK112349 Versaport V2 Bladeless Optiical Trocar and/or Versaport Bladeless…Covidien, Formerly US Surgical A Divison of Tyco H · 2011 · Recalled
- This deviceK153258 Medline ReNewal Reprocessed Versaport V2 Bladeless Optical TrocarsSurgical Instrument Service and Savings (Dba Medline Renewal · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K011257 | Endopath Non-Bladed Obturator Trocar System (5 MM) | Ethicon Endo-Surgery, Inc. | 2001 | — |
| −1 | K112349 | Versaport V2 Bladeless Optiical Trocar and/or Versaport Bladeless Optical Trocar | Covidien, Formerly US Surgical A Divison of Tyco H | 2011 | 6 |
| 0 (this device) | K153258 | Medline ReNewal Reprocessed Versaport V2 Bladeless Optical Trocars | Surgical Instrument Service and Savings (Dba Medline Renewal | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 NLM? 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 NLM device
- #1 K201511 Reprocessed Endoscopic Trocars and Sleevesscore -1.9 · 2 generations · no Class I recall
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 |
|---|---|---|---|
| * | K112349 | Versaport V2 Bladeless Optiical Trocar and/or Versaport Bladeless Optical TrocarSummary page 5…Product code: NLM Classification Class: Class II, non-exempt Classification Number: 21 CFR § 876.1500 K112349 Covidien Versaport V2 Bladeless Optical Trocar (11-mm and 12- Predicate Device mm trocars) Reference… | 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 15 years and passes through 3 companies; a new generation was cleared every 10.1 years on median.
- 1 of the 3 ancestors has a recall of any class.
- 4 other devices also cite its predicate K112349.
How does its category compare?
All NLM devicesNLM Laparoscope, General & Plastic Surgery, Reprocessed: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · NLM
1in 2020
2026 to Oct 25, outlined.
Median 510(k) review, days · NLM
284in 2007
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NLM
6so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NLM
10in 2025
MAUDE reports naming product code NLM, 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 | 4 | 284 | 0 | 2 |
| 2008 | 0 | — | 1 | 1 |
| 2009 | 0 | — | 0 | 2 |
| 2010 | 1 | — | 1 | 11 |
| 2011 | 1 | — | 0 | 7 |
| 2012 | 1 | — | 0 | 82 |
| 2013 | 1 | — | 0 | 102 |
| 2014 | 1 | — | 0 | 84 |
| 2015 | 0 | — | 0 | 27 |
| 2016 | 2 | — | 1 | 39 |
| 2017 | 2 | — | 0 | 15 |
| 2018 | 0 | — | 1 | 9 |
| 2019 | 1 | — | 0 | 6 |
| 2020 | 1 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 5 |
| 2022 | 0 | — | 0 | 5 |
| 2023 | 0 | — | 0 | 5 |
| 2024 | 0 | — | 0 | 4 |
| 2025 | 0 | — | 0 | 10 |
| 2026 | 0 | — | 6 | — |
What is it indicated for?
The Medline ReNewal Reprocessed Versaport V2 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/K153258 · printed Nov 6, 2026
Cite this page
510(k) Report. “K153258: Medline ReNewal Reprocessed Versaport V2 Bladeless Optical Trocars.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K153258
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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