510(k) · Cleared
ClearedMicrosurgeon Microwave Tissue Ablation Device, Model Mtad-100
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Microsurgeon, Inc. · NEY System, Ablation, Microwave And Accessories
Cleared on Aug 15, 2007 as substantially equivalent to K003978 (Afx, Inc., 2001) and 2 other predicates after a 224-day review. Its family tree reaches back 4 generations to 1981. 41 later devices descend from it.
- Decided
- Aug 15, 2007
- Review
- 224 days
- Class
- Class II
- Product code
- NEY
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K811390 (1981). 16 ancestors in all. 41 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK811390 CCS100 Cryosurgical SystemFrigitronics of Connecticut, Inc. · 1981
- 3 generations backK972662 Cryogen Cryosurgical SystemCryogen, Inc. · 1997
- 2 generations backK974320 Cryogen Cardiac Cryosurgical SystemCryogen, Inc. · 1998
- 1 generation backK013946 Flex 10 Accessory for the Afx Microwave Ablation SystemAfx, Inc. · 2002
- This deviceK070023 Microsurgeon Microwave Tissue Ablation Device, Model Mtad-100Microsurgeon, Inc. · 2007
- Descendant · cites it directly · 39 of its ownK100744 Certus 140 Microwave Ablation System and Accessories, Model Certus 140Neuwave Medical, Inc. · 2010
- Descendant · 2 generations on · 38 of its ownK113237 Certus 140 2.45GHZ Ablation SystemNeuwave Medical, Inc. · 2012
- Descendant · 3 generations on · 29 of its ownK133821 Emprint Ablation SystemCovidien, LLC · 2014 · Recalled
- Descendant · 4 generations on · 13 of its ownK163105 Emprint Ablation SystemCovidien, LLC · 2016 · Recalled
- Descendant · 4 generations on · 9 of its ownK183153 Microwave Ablation SystemSurgnova Healthcare Technologies (Zhejiang) Co., Ltd. · 2019
Showing 5 of 41 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 41 · See all- K100744Certus 140 Microwave Ablation System and Accessories, Model Certus 140Neuwave Medical, Inc. · 2010 · cites it directly39descendants
- K113237Certus 140 2.45GHZ Ablation SystemNeuwave Medical, Inc. · 2012 · 2 generations on38descendants
- K133821Emprint Ablation SystemCovidien, LLC · 2014 · 3 generations on29descendants
- K163105Emprint Ablation SystemCovidien, LLC · 2016 · 4 generations on13descendants
- K183153Microwave Ablation SystemSurgnova Healthcare Technologies (Zhejiang) Co., Ltd. · 2019 · 4 generations on9descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K811390 | CCS100 Cryosurgical System | Frigitronics of Connecticut, Inc. | 1981 | — |
| −3 | K972662 | Cryogen Cryosurgical System | Cryogen, Inc. | 1997 | — |
| −2 | K974320 | Cryogen Cardiac Cryosurgical System | Cryogen, Inc. | 1998 | — |
| −1 | K013946 | Flex 10 Accessory for the Afx Microwave Ablation System | Afx, Inc. | 2002 | — |
| 0 (this device) | K070023 | Microsurgeon Microwave Tissue Ablation Device, Model Mtad-100 | Microsurgeon, Inc. | 2007 | — |
| +1 | K100744 | Certus 140 Microwave Ablation System and Accessories, Model Certus 140 | Neuwave Medical, Inc. | 2010 | — |
| +2 | K113237 | Certus 140 2.45GHZ Ablation System | Neuwave Medical, Inc. | 2012 | — |
| +3 | K133821 | Emprint Ablation System | Covidien, LLC | 2014 | 7 |
| +4 | K163105 | Emprint Ablation System | Covidien, LLC | 2016 | 3 |
| +4 | K183153 | Microwave Ablation System | Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 2 | 0 |
| 1988 | 1 | 0 |
| 1991 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 2 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 6 | 0 |
| 2021 | 3 | 0 |
| 2022 | 1 | 0 |
| 2023 | 6 | 0 |
| 2024 | 7 | 0 |
| 2025 | 2 | 0 |
| 2026 | 2 | 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? (3)
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 |
|---|---|---|---|
| * | K003978 | Afx Microwave Generator, Flex Ablation Wand, Lynx Ablation Wand, Model Series 1000, P/N…Summary page 2…PREDICATE DEVICE: The legally marketed device/s to which equivalence is being claimed is: Afx, hic 47929 Fremont Blvd Fremont, CA 94538 K003978: Microwave Ablation System & Accessories K013946: Flex 10 Accessory for the Microwave Ablation System Vivant Medical… | 2001 |
| * | K013946 | Flex 10 Accessory for the Afx Microwave Ablation SystemSummary page 2…s to which equivalence is being claimed is: Afx, hic 47929 Fremont Blvd Fremont, CA 94538 K003978: Microwave Ablation System & Accessories K013946: Flex 10 Accessory for the Microwave Ablation System Vivant Medical, Inc 1916-A Old Middlefield Way Mountain V… | 2002 |
| * | K011676 | Vivawave Microwave SystemSummary page 2…sories K013946: Flex 10 Accessory for the Microwave Ablation System Vivant Medical, Inc 1916-A Old Middlefield Way Mountain View, CA 94043 K01 1676: Microwave Ablation System & Accessories 6. Device Description The MicroSurgeon Microwave Soft Tissue Ablation device mod… | 2002 |
What descends from it? (41)
See all 412 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 26 years and passes through 4 companies; a new generation was cleared every 5.5 years on median.
- 1 of the 16 ancestors has a recall of any class.
- Of its descendants, K100744 (Neuwave Medical, Inc., 2010) has gone furthest, with 39 descendants of its own.
- 11 other devices also cite its predicate K003978.
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 MicroSurgeon Microwave Soft Tissue Ablation Device is intended to be used for the surgical ablation of soft tissue.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K070023 · printed Nov 4, 2026
Cite this page
510(k) Report. “K070023: Microsurgeon Microwave Tissue Ablation Device, Model Mtad-100.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K070023
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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