510(k) · Cleared
ClearedNes Reprocessed Endoscopic Trocar
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Northeast Scientific, Inc. · NLM Laparoscope, General & Plastic Surgery, Reprocessed
Cleared on Sep 7, 2007 as substantially equivalent to K011538 (Ethicon Endo-Surgery, Inc., 2001) and 4 other predicates after a 542-day review. Its family tree reaches back 1 generation to 1993.
- Decided
- Sep 7, 2007
- Review
- 542 days
- Class
- Class II
- Product code
- NLM
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 1 generation to K922608 (1993). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK922608 Endopath EP Disposable TrocarETHICON, Inc. · 1993
- This deviceK060676 Nes Reprocessed Endoscopic TrocarNortheast Scientific, Inc. · 2007
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K922608 | Endopath EP Disposable Trocar | ETHICON, Inc. | 1993 | — |
| 0 (this device) | K060676 | Nes Reprocessed Endoscopic Trocar | Northeast Scientific, Inc. | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 2 | 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? (5)
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 |
|---|---|---|---|
| * | K011538 | Endopath Non-Bladed Solid Obturator Trocar SystemSummary page 1…M Device Class: Class LI OEM Models: Ethicon XCEL B5LT Predicate Devices 510(k) # Trade Name K01 1538: Endopath® Non-Bladed Solid Obturator Trocar KO1 1257: Endopath® Non-Bladed Obturator Trocar Syst… | 2001 |
| * | K011257 | Endopath Non-Bladed Obturator Trocar System (5 MM) | 2001 |
| * | K990028 | Endopath Optiview Optical Surgical Obturator and SleeveSummary page 1…Solid Obturator Trocar KO1 1257: Endopath® Non-Bladed Obturator Trocar System (5mm) K990028: Endopath® Optiview® Optical Surgical Obturator and Sleeve K9717… | 1999 |
| * | K971738 | Endopath Resposable Trocar SystemSummary page 1…(5mm) K990028: Endopath® Optiview® Optical Surgical Obturator and Sleeve K971738: Ethicon Endopath® Resposable Trocar System K922608: Endopath® EP Disposable Surgical Trocar I… | 1997 |
| * | K922608 | Endopath EP Disposable TrocarSummary page 1…Surgical Obturator and Sleeve K971738: Ethicon Endopath® Resposable Trocar System K922608: Endopath® EP Disposable Surgical Trocar Indications for Use NES Reprocessed Endoscopic Trocars are indicated for use to… | 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 5 ancestors has a recall.
- 2 other devices also cite its predicate K011538.
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 milally invasive surgical procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060676 · printed Nov 4, 2026
Cite this page
510(k) Report. “K060676: Nes 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/K060676
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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