510(k) · Cleared
ClearedReprocessed Trocars
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ascent Healthcare Solutions · NLM Laparoscope, General & Plastic Surgery, Reprocessed
Cleared on Oct 2, 2007 as substantially equivalent to K032676 (Ethicon Endo-Surgery, Inc., 2003) after a 270-day review. Its family tree reaches back 1 generation to 2003. 1 later device descends from it.
- Decided
- Oct 2, 2007
- Review
- 270 days
- Class
- Class II
- Product code
- NLM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K032676 (2003). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK032676 Endopath Bladeless Trocar, Endopath Blunt Tip Trocar, Endopath…Ethicon Endo-Surgery, Inc. · 2003 · Recalled
- This deviceK070059 Reprocessed TrocarsAscent Healthcare Solutions · 2007
- Descendant · cites it directly · 0 of its ownK132629 Reprocessed Dilating Tip TrocarsStryker Sustainability Solutions · 2013
Most influential descendants
Showing 1 of 1 · See all- K132629Reprocessed Dilating Tip TrocarsStryker Sustainability Solutions · 2013 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K032676 | Endopath Bladeless Trocar, Endopath Blunt Tip Trocar, Endopath Dilating Tip… | Ethicon Endo-Surgery, Inc. | 2003 | 6 |
| 0 (this device) | K070059 | Reprocessed Trocars | Ascent Healthcare Solutions | 2007 | — |
| +1 | K132629 | Reprocessed Dilating Tip Trocars | Stryker Sustainability Solutions | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 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 |
|---|---|---|---|
| * | K032676 | Endopath Bladeless Trocar, Endopath Blunt Tip Trocar, Endopath Dilating Tip TrocarSummary page 1…Classification Name: Laparoscope, General and Plastic Surgery Predicate Device 510(k) Title Manufacturer K032676 ENDOPATH III Bladeless Trocars Ethicon Endo-Surgery ENDOPATH III Blunt Tip Trocars… | 2003 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K132629 | Reprocessed Dilating Tip Trocars | 2013 | 0 |
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?
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. 2007, 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?
Reprocessed Endoscopic Trocars are indicated for use to establish a port of entry for endoscopic instruments in patients requiring minimally invasive surgical procedures including thoracic, gynecologic laparoscopy and other abdominal procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K070059 · printed Nov 4, 2026
Cite this page
510(k) Report. “K070059: Reprocessed Trocars.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K070059
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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