510(k) · Cleared
ClearedReprocessed Ethicon Bladeless Trocars; Reprocessed Ethicon Universal Trocar Sleeves
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Renovo, Inc. · NLM Laparoscope, General & Plastic Surgery, Reprocessed
Cleared on Oct 6, 2017 as substantially equivalent to K122511 (Ethicon Endo-Surgery, LLC, 2012) after an 87-day review. Its family tree reaches back 2 generations to 2003.
- Decided
- Oct 6, 2017
- Review
- 87 days
- Class
- Class II
- Product code
- NLM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K032676 (2003). No later device cites it as a predicate yet.
- Root · 2 generations backK032676 Endopath Bladeless Trocar, Endopath Blunt Tip Trocar, Endopath…Ethicon Endo-Surgery, Inc. · 2003 · Recalled
- 1 generation backK122511 Endopath Xcel Bladeless Trocar with Optiview Technology Endopath…Ethicon Endo-Surgery, LLC · 2012
- This deviceK172097 Reprocessed Ethicon Bladeless Trocars; Reprocessed Ethicon Universal…Renovo, Inc. · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K032676 | Endopath Bladeless Trocar, Endopath Blunt Tip Trocar, Endopath Dilating Tip… | Ethicon Endo-Surgery, Inc. | 2003 | 6 |
| −1 | K122511 | Endopath Xcel Bladeless Trocar with Optiview Technology Endopath Xcel Blunt… | Ethicon Endo-Surgery, LLC | 2012 | — |
| 0 (this device) | K172097 | Reprocessed Ethicon Bladeless Trocars; Reprocessed Ethicon Universal Trocar… | Renovo, Inc. | 2017 | — |
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 |
|---|---|---|---|
| * | K122511 | Endopath Xcel Bladeless Trocar with Optiview Technology Endopath Xcel Blunt Tip Trocar…Summary page 5…urer: Ethicon Endo-Surgery, LLC Predicate Trade Name: ENDOPATH® XCEL® Trocar with OPTIVIEWŒ7HFKQRORJ\ Predicate 510(k): K122511 No reference devices were used in this submission. V. DEVICE DESCRIPTION A trocar is a sterile device used in… | 2012 |
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 14 years and passes through 3 companies; a new generation was cleared every 8.9 years on median.
- 1 of the 2 ancestors has a recall of any class.
- 6 other devices also cite its predicate K122511.
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. 2017, 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 Reprocessed Ethicon Bladeless Trocars are intended for use in thoracic, gynecologic, laparoscopic and other abdominal or minimally invasive surgical procedures to establish a path of entry for endoscopic or minimally invasive instruments. The reprocessed optical trocar may be used with or without visualization for primary and secondary insertions.
The Reprocessed Ethicon Universal Trocar Sleeves are intended for use in thoracic, gynecologic, laparoscopic and other abdominal procedures to establish a path of entry for endoscopic instruments.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K172097 · printed Nov 6, 2026
Cite this page
510(k) Report. “K172097: Reprocessed Ethicon Bladeless Trocars; Reprocessed Ethicon Universal Trocar Sleeves.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K172097
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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