510(k) · Cleared
ClearedGyrus Ent Nerve Stimulator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Gyrus Ent LLC · ETN Stimulator, Nerve
Cleared on Oct 24, 2002 after a 162-day review. The FDA summary names its predicate without a number. 4 later devices descend from it.
- Decided
- Oct 24, 2002
- Review
- 162 days
- Class
- Class II
- Product code
- ETN
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 1 citing it directly.
- This deviceK021595 Gyrus Ent Nerve StimulatorGyrus Ent LLC · 2002
- Descendant · cites it directly · 3 of its ownK063560 Hilger Dual-Stim Nerve StimulatorWr Medical Electronics Co. · 2007
- Descendant · 2 generations on · 2 of its ownK081742 Baxano Neural Localization Probe 1.75 and 1.25Baxano, Inc. · 2008
- Descendant · 3 generations on · 1 of its ownK092729 Baxano Neuro Check DeviceBaxano, Inc. · 2009
- Descendant · 4 generations on · 0 of its ownK110696 Neuro Check Device with IO-Flex WireBaxano, Inc. · 2011
Most influential descendants
Showing 4 of 4 · See all- K063560Hilger Dual-Stim Nerve StimulatorWr Medical Electronics Co. · 2007 · cites it directly3descendants
- K081742Baxano Neural Localization Probe 1.75 and 1.25Baxano, Inc. · 2008 · 2 generations on2descendants
- K092729Baxano Neuro Check DeviceBaxano, Inc. · 2009 · 3 generations on1descendant
- K110696Neuro Check Device with IO-Flex WireBaxano, Inc. · 2011 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K021595 | Gyrus Ent Nerve Stimulator | Gyrus Ent LLC | 2002 | — |
| +1 | K063560 | Hilger Dual-Stim Nerve Stimulator | Wr Medical Electronics Co. | 2007 | — |
| +2 | K081742 | Baxano Neural Localization Probe 1.75 and 1.25 | Baxano, Inc. | 2008 | — |
| +3 | K092729 | Baxano Neuro Check Device | Baxano, Inc. | 2009 | — |
| +4 | K110696 | Neuro Check Device with IO-Flex Wire | Baxano, Inc. | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 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 ETN? 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 ETN device
- #1 K251672 NIM Essence™ EMG Endotracheal Tube…score 12.3 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
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 |
|---|---|---|---|
| * | — | Neurosign Model 100 Neural Tissue Stimulator Named without a submission number |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K063560 | Hilger Dual-Stim Nerve Stimulator | 2007 | 3 |
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?
- Of its descendants, K063560 (Wr Medical Electronics Co., 2007) has gone furthest, with 3 descendants of its own.
How does its category compare?
All ETN devicesETN Stimulator, Nerve: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · ETN
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · ETN
98in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · ETN
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · ETN
1,145in 2025
MAUDE reports naming product code ETN, 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 | 2 | — | 0 | 5 |
| 2008 | 2 | — | 1 | 5 |
| 2009 | 5 | 115 | 0 | 22 |
| 2010 | 3 | 168 | 1 | 26 |
| 2011 | 9 | 115 | 0 | 55 |
| 2012 | 7 | 179 | 0 | 187 |
| 2013 | 1 | — | 0 | 270 |
| 2014 | 2 | — | 0 | 137 |
| 2015 | 1 | — | 0 | 202 |
| 2016 | 2 | — | 1 | 145 |
| 2017 | 0 | — | 0 | 117 |
| 2018 | 0 | — | 0 | 250 |
| 2019 | 0 | — | 2 | 314 |
| 2020 | 1 | — | 1 | 238 |
| 2021 | 1 | — | 1 | 197 |
| 2022 | 2 | — | 0 | 247 |
| 2023 | 5 | 98 | 1 | 390 |
| 2024 | 2 | — | 0 | 748 |
| 2025 | 1 | — | 0 | 1,145 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The Gyrus ENT Nerve Stimulator is intended to provide electrical stimulation to cranial and peripheral motor nerves to aid in nerve location during 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/K021595 · printed Nov 6, 2026
Cite this page
510(k) Report. “K021595: Gyrus Ent Nerve Stimulator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K021595
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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