510(k) · Cleared
ClearedModification to Medwaves 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 Jan 15, 2009 as substantially equivalent to K070356 (Medwaves Incorporated, 2007) after a 48-day review. Its family tree reaches back 7 generations to 1986. 1 later device descends from it.
- Decided
- Jan 15, 2009
- Review
- 48 days
- Class
- Class II
- Product code
- NEY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K861904 (1986). 19 ancestors in all, the oldest K790187 (1979). 1 later device descends from it, 1 citing it directly.
- Root · 7 generations backK861904 HS-15M Microwave Surgery Equipment, MicrotazeCooper Lasersonics, Inc. · 1986
- 6 generations backK011676 Vivawave Microwave SystemVivant Medical, Inc. · 2002 · Recalled
- 5 generations backK023311 Loop Microwave Ablation ProbeVivant Medical, Inc. · 2003
- 4 generations backK032047 Tri-Loop Microwave Ablation ProbeVivant Medical, Inc. · 2003
- 3 generations backK032702 Vivatip Microwave Ablation ProbeVivant Medical, Inc. · 2003
- 2 generations backK052919 Microsulis Tissue Ablation SystemMicrosulis Americas, Inc. · 2006
- 1 generation backK070356 Medwaves Microwave Coagulation/Ablation SystemMedwaves Incorporated · 2007
- This deviceK083537 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 1 of 1 · See all- K143203AveCure Microwave Coagulation-Ablation Generator, AveCure Microwave Large Antenna-Probe…Medwaves Incorporated · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K861904 | HS-15M Microwave Surgery Equipment, Microtaze | Cooper Lasersonics, Inc. | 1986 | — |
| −6 | K011676 | Vivawave Microwave System | Vivant Medical, Inc. | 2002 | 1 |
| −5 | K023311 | Loop Microwave Ablation Probe | Vivant Medical, Inc. | 2003 | — |
| −4 | K032047 | Tri-Loop Microwave Ablation Probe | Vivant Medical, Inc. | 2003 | — |
| −3 | K032702 | Vivatip Microwave Ablation Probe | Vivant Medical, Inc. | 2003 | — |
| −2 | K052919 | Microsulis Tissue Ablation System | Microsulis Americas, Inc. | 2006 | — |
| −1 | K070356 | Medwaves Microwave Coagulation/Ablation System | Medwaves Incorporated | 2007 | — |
| 0 (this device) | 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 |
|---|---|---|
| 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K070356 | Medwaves Microwave Coagulation/Ablation SystemSummary page 1…blation System is substantially equivalent to and is a modification to the Company's own medical device: MedWaves Microwave Coagulation/Ablation System K070356 4. Device Description The MedWaves Microwave Coagulation/Ablation System consists of a microwave generator and accessories used… | 2007 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K143203 | AveCure Microwave Coagulation-Ablation Generator, AveCure Microwave Large Antenna-Probe… | 2015 | 0 |
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 23 years and passes through 4 companies; a new generation was cleared every 1.1 years on median.
- 2 of the 19 ancestors have a recall of any class.
- Of its descendants, K143203 (Medwaves Incorporated, 2015) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K070356.
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. 2009, 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 surgical 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/K083537 · printed Nov 6, 2026
Cite this page
510(k) Report. “K083537: Modification to 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/K083537
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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