510(k) · Cleared
ClearedEntellus Medical Sinus Guidewire
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Entellus Medical, Inc. · LRC Instrument, Ent Manual Surgical
Cleared on Jun 14, 2011 as substantially equivalent to K033321 (Neometrics, Inc., 2003) and 1 other predicate after an 89-day review. Its family tree reaches back 3 generations to 2001.
- Decided
- Jun 14, 2011
- Review
- 89 days
- Class
- Class I
- Product code
- LRC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K011084 (2001). 4 ancestors in all, the oldest K943390 (1995). No later device cites it as a predicate yet.
- Root · 3 generations backK011084 Mandrel Guidewire AssemblyLake Region Mfg., Inc. · 2001
- 2 generations backK013024 Selectiva GuidewireNeometrics, Inc. · 2001
- 1 generation backK033321 Selectiva SB GuidewireNeometrics, Inc. · 2003
- This deviceK110739 Entellus Medical Sinus GuidewireEntellus Medical, Inc. · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K011084 | Mandrel Guidewire Assembly | Lake Region Mfg., Inc. | 2001 | — |
| −2 | K013024 | Selectiva Guidewire | Neometrics, Inc. | 2001 | — |
| −1 | K033321 | Selectiva SB Guidewire | Neometrics, Inc. | 2003 | — |
| 0 (this device) | K110739 | Entellus Medical Sinus Guidewire | Entellus Medical, Inc. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 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 LRC? 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 LRC device
- #1 K230258 BB 8 Sinus Dilation Kitscore 11.1 · 20 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K033321 | Selectiva SB GuidewireSummary page 1…ENT Device Classification: Class I Product Code: LRC Predicate Devices: Neoctrics SelectivaTM SB Guidewire [K033321, K013024] Relieva VigorTM Sinus Guidewire Device Description: Entellus Medical Sinus Guidewire is a 0.035" - compatible guidewir… | 2003 |
| * | K013024 | Selectiva GuidewireSummary page 1…Device Classification: Class I Product Code: LRC Predicate Devices: Neoctrics SelectivaTM SB Guidewire [K033321, K013024] Relieva VigorTM Sinus Guidewire Device Description: Entellus Medical Sinus Guidewire is a 0.035" - compatible guidewire with a… | 2001 |
| * | — | Relieva Vigor™ Sinus Guidewire Named without a submission number |
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?
- The line of descent spans 10 years and passes through 3 companies; a new generation was cleared every 1.9 years on median.
- None of the 4 ancestors has a recall.
How does its category compare?
All LRC devicesLRC Instrument, Ent Manual Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · LRC
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · LRC
131in 2020
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LRC
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LRC
44in 2025
MAUDE reports naming product code LRC, 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 | 0 | — | 0 | 1 |
| 2008 | 2 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 8 |
| 2010 | 2 | — | 0 | 11 |
| 2011 | 6 | 106 | 0 | 14 |
| 2012 | 7 | 50 | 0 | 48 |
| 2013 | 7 | 104 | 0 | 53 |
| 2014 | 3 | 29 | 0 | 53 |
| 2015 | 6 | 105 | 0 | 41 |
| 2016 | 3 | 100 | 0 | 39 |
| 2017 | 2 | — | 0 | 32 |
| 2018 | 1 | — | 0 | 42 |
| 2019 | 1 | — | 0 | 19 |
| 2020 | 4 | 131 | 0 | 20 |
| 2021 | 0 | — | 0 | 23 |
| 2022 | 1 | — | 0 | 25 |
| 2023 | 1 | — | 1 | 14 |
| 2024 | 0 | — | 1 | 51 |
| 2025 | 0 | — | 0 | 44 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
To provide a means to access the frontal, sphenoid and maxillary sinuses, for diagnostic and therapeutic procedures in adults aged 18 and over.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K110739 · printed Nov 6, 2026
Cite this page
510(k) Report. “K110739: Entellus Medical Sinus Guidewire.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K110739
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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