510(k) · Cleared
Recalled · Class II · 2026Reprocessed Endoscopic Trocars and Sleeves
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker Sustainability Solutions · NLM Laparoscope, General & Plastic Surgery, Reprocessed
Cleared on Jul 31, 2020 as substantially equivalent to K032676 (Ethicon Endo-Surgery, Inc., 2003) and 1 other predicate after a 56-day review. Its family tree reaches back 2 generations to 2003. It has been recalled 6 times.
- Decided
- Jul 31, 2020
- Review
- 56 days
- Class
- Class II
- Product code
- NLM
- Recalls
- 6
- Predicates
- 2
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 deviceK201511 Reprocessed Endoscopic Trocars and SleevesStryker Sustainability Solutions · 2020
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) | K201511 | Reprocessed Endoscopic Trocars and Sleeves | Stryker Sustainability Solutions | 2020 | — |
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.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K032676 | Endopath Bladeless Trocar, Endopath Blunt Tip Trocar, Endopath Dilating Tip TrocarSummary page 5…876.1500 Product Code: NLM Predicate Device: 510(k) Number 510(k) Title Original Manufacturer K032676 ENDOPATH III Bladeless Trocars ETHICON ENDO-SURGERY,… | 2003 |
| * | K122511 | Endopath Xcel Bladeless Trocar with Optiview Technology Endopath Xcel Blunt Tip Trocar…Summary page 5…N ENDO-SURGERY, LLC ENDOPATH XCEL TROCAR WITH ETHICON ENDO-SURGERY, K122511 OPTIVIEW TECHNOLOGY LLC… | 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 19, 2026 | Class II | Z-3187-2026 | Device Design | Reusable access port system may crack or seperate during use. |
| Aug 19, 2026 | Class II | Z-3186-2026 | Device Design | Reusable access port system may crack or seperate during use. |
| Aug 19, 2026 | Class II | Z-3185-2026 | Device Design | Reusable access port system may crack or seperate during use. |
| Aug 19, 2026 | Class II | Z-3183-2026 | Device Design | Reusable access port system may crack or seperate during use. |
| Aug 19, 2026 | Class II | Z-3182-2026 | Device Design | Reusable access port system may crack or seperate during use. |
| Aug 19, 2026 | Class II | Z-3184-2026 | Device Design | Reusable access port system may crack or seperate during use. |
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?
- The line of descent spans 17 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.
- 25 other devices also cite its predicate K032676.
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. 2020, 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 Endoscopic Trocars and Sleeves (B11LT, B12LT, B5LT, B5ST, CB11LT, CB12LT, CB5LT, CB5ST, D11LT, D12LT, D5LT, D5ST, H12LP, 2B5LT, 2B5ST, 2D5LT, 2D5ST, 2CB5ST, 2CB5LT) have applications in abdominal, thoracic, and gynecologic minimally invasive surgical procedures to establish a path of entry for endoscopic instruments. The Bladeless Trocars 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/K201511 · printed Nov 6, 2026
Cite this page
510(k) Report. “K201511: Reprocessed Endoscopic Trocars and Sleeves.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K201511
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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