510(k) · Cleared
Recalled · 2006Smith & Nephew Dyonics Electroblade Resector
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Smith & Nephew, Inc. · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Jun 20, 2003 after a 21-day review. The FDA summary names its predicate without a number. 51 later devices descend from it. It has been recalled 4 times.
- Decided
- Jun 20, 2003
- Review
- 21 days
- Class
- Class II
- Product code
- GEI
- Recalls
- 4
- Predicates
- 0
51 later devices descend from it, 1 citing it directly.
- This deviceK031675 Smith & Nephew Dyonics Electroblade ResectorSmith & Nephew, Inc. · 2003
- Descendant · cites it directly · 50 of its ownK034004 Diego RF Powered Dissector and Drill System ConsoleGyrus Ent LLC · 2004
- Descendant · 2 generations on · 44 of its ownK072302 Entellus Medical RS-Series SystemEntellus Medical, Inc. · 2008
- Descendant · 3 generations on · 42 of its ownK081542 Modification to Entellus Medical RS-Series SystemEntellus Medical, Inc. · 2008
- Descendant · 4 generations on · 41 of its ownK093007 Entellus Medical Balloon DeviceEntellus Medical, Inc. · 2010
- Descendant · 4 generations on · 36 of its ownK102003 Xpress Balloon DeviceEntellus Medical, Inc. · 2010
Showing 5 of 51 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 51 · See all- K034004Diego RF Powered Dissector and Drill System ConsoleGyrus Ent LLC · 2004 · cites it directly50descendants
- K072302Entellus Medical RS-Series SystemEntellus Medical, Inc. · 2008 · 2 generations on44descendants
- K081542Modification to Entellus Medical RS-Series SystemEntellus Medical, Inc. · 2008 · 3 generations on42descendants
- K093007Entellus Medical Balloon DeviceEntellus Medical, Inc. · 2010 · 4 generations on41descendants
- K102003Xpress Balloon DeviceEntellus Medical, Inc. · 2010 · 4 generations on36descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K031675 | Smith & Nephew Dyonics Electroblade Resector | Smith & Nephew, Inc. | 2003 | — |
| +1 | K034004 | Diego RF Powered Dissector and Drill System Console | Gyrus Ent LLC | 2004 | — |
| +2 | K072302 | Entellus Medical RS-Series System | Entellus Medical, Inc. | 2008 | — |
| +3 | K081542 | Modification to Entellus Medical RS-Series System | Entellus Medical, Inc. | 2008 | — |
| +4 | K093007 | Entellus Medical Balloon Device | Entellus Medical, Inc. | 2010 | — |
| +4 | K102003 | Xpress Balloon Device | Entellus Medical, Inc. | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2008 | 3 | 0 |
| 2010 | 2 | 0 |
| 2011 | 5 | 0 |
| 2012 | 7 | 0 |
| 2013 | 6 | 0 |
| 2014 | 2 | 0 |
| 2015 | 4 | 0 |
| 2016 | 4 | 0 |
| 2017 | 3 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 3 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 4 | 0 |
| 2026 | 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 GEI? 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 GEI device
- #1 K231790 The InMode System with the Morpheus8 Applicatorsscore 32.7 · 21 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
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 |
|---|---|---|---|
| * | — | 4.5mm Full Radius Bipolar ElectroBladeTM Named without a submission number | |
| * | — | 4.5mm Full Radius Elite Bipolar ElectroBladeTM Named without a submission number |
What descends from it? (51)
See all 511 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K034004 | Diego RF Powered Dissector and Drill System Console | 2004 | 50 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 19, 2006 | Not classified | Z-1231-06 | Other | Sterility seal of the package tray may have gaps/voids compromising the sterility of the device. |
| Jun 19, 2006 | Not classified | Z-1230-06 | Other | Sterility seal of the package tray may have gaps/voids compromising the sterility of the device. |
| Jun 19, 2006 | Not classified | Z-1233-06 | Other | Sterility seal of the package tray may have gaps/voids compromising the sterility of the device. |
| Jun 19, 2006 | Not classified | Z-1232-06 | Other | Sterility seal of the package tray may have gaps/voids compromising the sterility of the device. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K034004 (Gyrus Ent LLC, 2004) has gone furthest, with 50 descendants of its own.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GEI
52in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GEI
113in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GEI
4in 2025
Class I (14 since 2007) Class II/III not classified
Adverse event reports per year · GEI
7,592in 2025
MAUDE reports naming product code GEI, 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 | 50 | 51 | 21 | 2,795 |
| 2008 | 61 | 71 | 19 | 2,556 |
| 2009 | 42 | 130 | 27 | 3,591 |
| 2010 | 46 | 109 | 51 | 3,377 |
| 2011 | 35 | 135 | 32 | 4,463 |
| 2012 | 39 | 133 | 30 | 5,216 |
| 2013 | 48 | 136 | 13 | 4,897 |
| 2014 | 49 | 103 | 3 | 4,908 |
| 2015 | 47 | 123 | 4 | 4,936 |
| 2016 | 64 | 108 | 3 | 5,616 |
| 2017 | 52 | 72 | 2 | 6,073 |
| 2018 | 47 | 93 | 6 | 6,545 |
| 2019 | 48 | 93 | 5 | 7,067 |
| 2020 | 59 | 105 | 1 | 6,490 |
| 2021 | 46 | 146 | 6 | 6,354 |
| 2022 | 55 | 150 | 49 | 6,103 |
| 2023 | 65 | 104 | 27 (4) | 7,176 |
| 2024 | 59 | 125 | 22 (10) | 7,897 |
| 2025 | 52 | 113 | 4 | 7,592 |
| 2026 | 43 | 183 | 8 | — |
What is it indicated for?
The Smith & Nephew Dyonics® ElectroBladeTM Resector is indicated in arthroscopic surgical procedures of large and small articular cavities for resection and excision of soft and osseous tissues. The Smith & Nephew Dyonics® ElectroBladeTM Resector is effective in tissue resection and hemostasis of bleeding vessels. It is intended for arthroscopic procedures using saline solution, Ringer's lactate or other conductive solutions as an irrigant under direct or video-assisted fiber-optic visualization.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K031675 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031675: Smith & Nephew Dyonics Electroblade Resector.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031675
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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