510(k) · Cleared
ClearedVivawave Microwave Ablation System, Coaxial Introducer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vivant Medical, Inc. · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Feb 24, 2005 after a 24-day review. The summary cites one number, which could not be confirmed as its predicate (see the table below). 3 later devices descend from it.
- Decided
- Feb 24, 2005
- Review
- 24 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 1
3 later devices descend from it, 1 citing it directly.
- This deviceK050223 Vivawave Microwave Ablation System, Coaxial IntroducerVivant Medical, Inc. · 2005
- Descendant · cites it directly · 2 of its ownK081042 Microthermx-100 Microwave Ablation System and AccessoriesBsd Medical Systems Corp. · 2008
- Descendant · 2 generations on · 1 of its ownK100786 Microthermx Microwave Ablation System, Models MTX-180 or MTXBsd Medical Corp. · 2010
- Descendant · 3 generations on · 0 of its ownK141785 Micro Thermx Microwave Ablation System and AccessoriesBsd Medical Corp. · 2015
Most influential descendants
Showing 3 of 3 · See all- K081042Microthermx-100 Microwave Ablation System and AccessoriesBsd Medical Systems Corp. · 2008 · cites it directly2descendants
- K100786Microthermx Microwave Ablation System, Models MTX-180 or MTXBsd Medical Corp. · 2010 · 2 generations on1descendant
- K141785Micro Thermx Microwave Ablation System and AccessoriesBsd Medical Corp. · 2015 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K050223 | Vivawave Microwave Ablation System, Coaxial Introducer | Vivant Medical, Inc. | 2005 | — |
| +1 | K081042 | Microthermx-100 Microwave Ablation System and Accessories | Bsd Medical Systems Corp. | 2008 | — |
| +2 | K100786 | Microthermx Microwave Ablation System, Models MTX-180 or MTX | Bsd Medical Corp. | 2010 | — |
| +3 | K141785 | Micro Thermx Microwave Ablation System and Accessories | Bsd Medical Corp. | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2015 | 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? (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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K041167 | FDA’s K041167 is Pioneer Surgical Technology Quantum Spinal System Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2004 |
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 |
|---|---|---|---|
| K081042 | Microthermx-100 Microwave Ablation System and Accessories | 2008 | 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, K081042 (Bsd Medical Systems Corp., 2008) 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?
The VivaWave TM Microwave Ablation System is intended for coagulation of soft tissue. The Coaxial Introducer is intended to aid insertion of the microwave energy applicator component of the system. The system is not intended for use in cardiac procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K050223 · printed Nov 6, 2026
Cite this page
510(k) Report. “K050223: Vivawave Microwave Ablation System, Coaxial Introducer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050223
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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