510(k) · Cleared
ClearedReprocessed Endoscopic Trocar
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sterilmed, Inc. · NLM Laparoscope, General & Plastic Surgery, Reprocessed
Cleared on Nov 7, 2001 as substantially equivalent to K922608 (ETHICON, Inc., 1993) and 1 other predicate after a 90-day review. Its family tree reaches back 1 generation to 1993.
- Decided
- Nov 7, 2001
- Review
- 90 days
- Class
- Class II
- Product code
- NLM
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K925860 (1993). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK925860 Modified Auto Suture Surgiport Premium SealUnited States Surgical, A Division of Tyco Healthc · 1993
- This deviceK012578 Reprocessed Endoscopic TrocarSterilmed, Inc. · 2001
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K925860 | Modified Auto Suture Surgiport Premium Seal | United States Surgical, A Division of Tyco Healthc | 1993 | — |
| 0 (this device) | K012578 | Reprocessed Endoscopic Trocar | Sterilmed, Inc. | 2001 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 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? (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 |
|---|---|---|---|
| * | K922608 | Endopath EP Disposable TrocarSummary page 5…7, 2001 Trocar and Cannula Class II, 21 CFR 876.1500 GCJ The reprocessed endoscopic trocar is substantially equivalent to the Endopath EP Disposable Surgical Trocar (K922608), manufactured by Ethicon; AutoSuture Surgiport® Endoscopic Trocar (K925860), manufactured by US Surgical; and the counterpart de… | 1993 |
| * | K925860 | Modified Auto Suture Surgiport Premium SealSummary page 5…endoscopic trocar is substantially equivalent to the Endopath EP Disposable Surgical Trocar (K922608), manufactured by Ethicon; AutoSuture Surgiport® Endoscopic Trocar (K925860), manufactured by US Surgical; and the counterpart devices from the original manufacturer. Reprocessed endoscopic trocars are de… | 1993 |
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?
- None of the 2 ancestors has a recall.
- 2 other devices also cite its predicate K922608.
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.
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 are intended to provide a pathway for entry of minimally invasive instruments to a body organ or cavity during general, abdominal, thoracic, gynecological or other minimally invasive surgical procedures.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K012578 · printed Nov 6, 2026
Cite this page
510(k) Report. “K012578: Reprocessed Endoscopic Trocar.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K012578
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026