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 May 23, 2005 as substantially equivalent to K922608 (ETHICON, Inc., 1993) and 1 other predicate after a 145-day review. Its family tree reaches back 1 generation to 1993. 1 later device descends from it.
- Decided
- May 23, 2005
- Review
- 145 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. 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK925860 Modified Auto Suture Surgiport Premium SealUnited States Surgical, A Division of Tyco Healthc · 1993
- This deviceK043592 Reprocessed Endoscopic TrocarSterilmed, Inc. · 2005
- Descendant · cites it directly · 0 of its ownK052299 Reprocessed Endoscopic TrocarSterilmed, Inc. · 2006
Most influential descendants
Showing 1 of 1 · See all- K052299Reprocessed Endoscopic TrocarSterilmed, Inc. · 2006 · cites it directly0descendants
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) | K043592 | Reprocessed Endoscopic Trocar | Sterilmed, Inc. | 2005 | — |
| +1 | K052299 | Reprocessed Endoscopic Trocar | Sterilmed, Inc. | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 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 1…rocessed endoscopic trocar is substantially equivalent to the Endopath EP Disposable Surgical Trocar (K922608), manufactured by Ethicon and AutoSuture Surgiport® Endoscopic Trocar (K925860) manufactured… | 1993 |
| * | K925860 | Modified Auto Suture Surgiport Premium SealSummary page 1…sable Surgical Trocar (K922608), manufactured by Ethicon and AutoSuture Surgiport® Endoscopic Trocar (K925860) manufactured by US Surgical. Device Description: Reprocessed endoseopic trocars… | 1993 |
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 |
|---|---|---|---|
| K052299 | Reprocessed Endoscopic Trocar | 2006 | 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.
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 designed to provide a pathway for entry of minimally invasive instruments to a body organ or cavity during general, abdominal, thoracic, gynecologic or other minimally invasive surgical procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K043592 · printed Nov 4, 2026
Cite this page
510(k) Report. “K043592: Reprocessed Endoscopic Trocar.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K043592
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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