510(k) · Cleared
ClearedConmed Heatwave Hand-Controlled Eletrode
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Conmedcorp · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Jun 26, 2002 after a 63-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 3 later devices descend from it.
- Decided
- Jun 26, 2002
- Review
- 63 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 1 citing it directly.
- This deviceK021299 Conmed Heatwave Hand-Controlled EletrodeConmedcorp · 2002
- Descendant · cites it directly · 2 of its ownK050923 Lightwave Integrated Electrode Ablator and Light Wave Integrated…Conmed Linvatec · 2005 · Recalled
- Descendant · 2 generations on · 0 of its ownK083281 EL Lightwave Suction Ablator, Model EL-2000-S, Lightwave Suction…Linvatec Corp. · 2009
- Descendant · 2 generations on · 0 of its ownK052692 Suretek Medical Reprocessed Electrosurgical ElectrodesSuretek Medical · 2006
Most influential descendants
Showing 3 of 3 · See all- K050923Lightwave Integrated Electrode Ablator and Light Wave Integrated Electrode Suction AblatorConmed Linvatec · 2005 · cites it directly2descendants
- K083281EL Lightwave Suction Ablator, Model EL-2000-S, Lightwave Suction Ablator, Model…Linvatec Corp. · 2009 · 2 generations on0descendants
- K052692Suretek Medical Reprocessed Electrosurgical ElectrodesSuretek Medical · 2006 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K021299 | Conmed Heatwave Hand-Controlled Eletrode | Conmedcorp | 2002 | — |
| +1 | K050923 | Lightwave Integrated Electrode Ablator and Light Wave Integrated Electrode… | Conmed Linvatec | 2005 | 1 |
| +2 | K083281 | EL Lightwave Suction Ablator, Model EL-2000-S, Lightwave Suction Ablator… | Linvatec Corp. | 2009 | — |
| +2 | K052692 | Suretek Medical Reprocessed Electrosurgical Electrodes | Suretek Medical | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2009 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K050923 | Lightwave Integrated Electrode Ablator and Light Wave Integrated Electrode Suction Ablator | 2005 | 2 |
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, K050923 (Conmed Linvatec, 2005) has gone furthest, with 2 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?
For electrosurgical cutting and coagulation in shoulder, ankle, wrist, elbow,
and knee arthroscopic procedures. Additionally, the SI version also has
suction capability.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K021299 · printed Nov 6, 2026
Cite this page
510(k) Report. “K021299: Conmed Heatwave Hand-Controlled Eletrode.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K021299
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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