510(k) · Cleared
ClearedMedwaves Microwave Coagulation/Ablation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medwaves Incorporated · NEY System, Ablation, Microwave And Accessories
Cleared on Dec 18, 2007 as substantially equivalent to K052919 (Microsulis Americas, Inc., 2006) and 3 other predicates after a 315-day review. Its family tree reaches back 6 generations to 1986. 2 later devices descend from it.
- Decided
- Dec 18, 2007
- Review
- 315 days
- Class
- Class II
- Product code
- NEY
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 6 generations to K861904 (1986). 18 ancestors in all, the oldest K790187 (1979). 2 later devices descend from it, 2 citing it directly.
- Root · 6 generations backK861904 HS-15M Microwave Surgery Equipment, MicrotazeCooper Lasersonics, Inc. · 1986
- 5 generations backK011676 Vivawave Microwave SystemVivant Medical, Inc. · 2002 · Recalled
- 4 generations backK023311 Loop Microwave Ablation ProbeVivant Medical, Inc. · 2003
- 3 generations backK032047 Tri-Loop Microwave Ablation ProbeVivant Medical, Inc. · 2003
- 2 generations backK032702 Vivatip Microwave Ablation ProbeVivant Medical, Inc. · 2003
- 1 generation backK052919 Microsulis Tissue Ablation SystemMicrosulis Americas, Inc. · 2006
- This deviceK070356 Medwaves Microwave Coagulation/Ablation SystemMedwaves Incorporated · 2007
- Descendant · cites it directly · 1 of its ownK083537 Modification to Medwaves Microwave Coagulation/Ablation SystemMedwaves Incorporated · 2009
- Descendant · cites it directly · 0 of its ownK143203 AveCure Microwave Coagulation-Ablation Generator, AveCure Microwave…Medwaves Incorporated · 2015
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K861904 | HS-15M Microwave Surgery Equipment, Microtaze | Cooper Lasersonics, Inc. | 1986 | — |
| −5 | K011676 | Vivawave Microwave System | Vivant Medical, Inc. | 2002 | 1 |
| −4 | K023311 | Loop Microwave Ablation Probe | Vivant Medical, Inc. | 2003 | — |
| −3 | K032047 | Tri-Loop Microwave Ablation Probe | Vivant Medical, Inc. | 2003 | — |
| −2 | K032702 | Vivatip Microwave Ablation Probe | Vivant Medical, Inc. | 2003 | — |
| −1 | K052919 | Microsulis Tissue Ablation System | Microsulis Americas, Inc. | 2006 | — |
| 0 (this device) | K070356 | Medwaves Microwave Coagulation/Ablation System | Medwaves Incorporated | 2007 | — |
| +1 | K083537 | Modification to Medwaves Microwave Coagulation/Ablation System | Medwaves Incorporated | 2009 | — |
| +1 | K143203 | AveCure Microwave Coagulation-Ablation Generator, AveCure Microwave Large… | Medwaves Incorporated | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1983 | 1 | 0 |
| 1984 | 2 | 0 |
| 1986 | 1 | 0 |
| 1996 | 3 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2003 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 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 NEY? 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 NEY device
- #1 K253771 Disposable Microwave Ablation Antenna…score 14.5 · 13 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
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 |
|---|---|---|---|
| * | K052919 | Microsulis Tissue Ablation SystemSummary page 1…on System is substantially equivalent to the following devices previously cleared via 510k by FDA: *Microsulis Tissue Ablation (MTA) System K05291 9 *Tyco/Radionics Cool-Ti pTm RF System K984552 *VivaWave TM Microwave Ablation System… | 2006 |
| * | K984552 | Cool-Tip RF SystemSummary page 1…viously cleared via 510k by FDA: *Microsulis Tissue Ablation (MTA) System K05291 9 *Tyco/Radionics Cool-Ti pTm RF System K984552 *VivaWave TM Microwave Ablation System K01 1676 \AVvaWave TM Microwave Ablation System… | 1999 |
| * | K011676 | Vivawave Microwave SystemSummary page 1…on (MTA) System K05291 9 *Tyco/Radionics Cool-Ti pTm RF System K984552 *VivaWave TM Microwave Ablation System K01 1676 \AVvaWave TM Microwave Ablation System K053535 4. Device Description The MedWaves Microwave C… | 2002 |
| * | K053535 | Vivawave Microwave Ablation SystemSummary page 1…Tm RF System K984552 *VivaWave TM Microwave Ablation System K01 1676 \AVvaWave TM Microwave Ablation System K053535 4. Device Description The MedWaves Microwave Coagulation/Ablation System consists of a microwave generator and… | 2006 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 21 years and passes through 4 companies; a new generation was cleared every 1.9 years on median.
- 2 of the 18 ancestors have a recall of any class.
- Of its descendants, K083537 (Medwaves Incorporated, 2009) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K052919.
How does its category compare?
All NEY devicesNEY System, Ablation, Microwave And Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · NEY
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NEY
94in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NEY
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NEY
112in 2025
MAUDE reports naming product code NEY, 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 | 18 |
| 2008 | 3 | 145 | 0 | 15 |
| 2009 | 4 | 169 | 0 | 7 |
| 2010 | 3 | 219 | 0 | 28 |
| 2011 | 0 | — | 0 | 26 |
| 2012 | 3 | 81 | 0 | 9 |
| 2013 | 1 | — | 0 | 16 |
| 2014 | 1 | — | 0 | 27 |
| 2015 | 2 | — | 0 | 92 |
| 2016 | 3 | 30 | 0 | 176 |
| 2017 | 3 | 121 | 12 | 225 |
| 2018 | 3 | 90 | 3 | 102 |
| 2019 | 2 | — | 0 | 123 |
| 2020 | 7 | 178 | 0 | 128 |
| 2021 | 4 | 379 | 1 | 217 |
| 2022 | 1 | — | 1 | 142 |
| 2023 | 9 | 155 | 0 | 106 |
| 2024 | 7 | 94 | 0 | 141 |
| 2025 | 1 | — | 0 | 112 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The MedWaves Microwave Coagulation/Ablation System is intended for general surgery use in open procedures for the coagulation and ablation of soft tissues. The system is not intended for use in cardiac procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K070356 · printed Nov 6, 2026
Cite this page
510(k) Report. “K070356: Medwaves Microwave Coagulation/Ablation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070356
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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