510(k) · Cleared
ClearedLoop Microwave Ablation Probe
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 Apr 9, 2003 as substantially equivalent to K011676 (Vivant Medical, Inc., 2002) and 1 other predicate after a 188-day review. Its family tree reaches back 2 generations to 1986. 28 later devices descend from it.
- Decided
- Apr 9, 2003
- Review
- 188 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K861904 (1986). 7 ancestors in all, the oldest K790187 (1979). 28 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK861904 HS-15M Microwave Surgery Equipment, MicrotazeCooper Lasersonics, Inc. · 1986
- 1 generation backK011676 Vivawave Microwave SystemVivant Medical, Inc. · 2002 · Recalled
- This deviceK023311 Loop Microwave Ablation ProbeVivant Medical, Inc. · 2003
- Descendant · cites it directly · 27 of its ownK032047 Tri-Loop Microwave Ablation ProbeVivant Medical, Inc. · 2003
- Descendant · 2 generations on · 26 of its ownK032702 Vivatip Microwave Ablation ProbeVivant Medical, Inc. · 2003
- Descendant · 3 generations on · 15 of its ownK052919 Microsulis Tissue Ablation SystemMicrosulis Americas, Inc. · 2006
- Descendant · 4 generations on · 11 of its ownK072870 Microwave Tissue Coagulation System (MTCS)Foundry Newco X, Inc. · 2008
- Descendant · 5 generations on · 10 of its ownK082819 Dermatologic Treatment System (DTS) G2Miramar Labs, Inc. · 2009
Showing 5 of 28 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 28 · See all- K032047Tri-Loop Microwave Ablation ProbeVivant Medical, Inc. · 2003 · cites it directly27descendants
- K032702Vivatip Microwave Ablation ProbeVivant Medical, Inc. · 2003 · 2 generations on26descendants
- K052919Microsulis Tissue Ablation SystemMicrosulis Americas, Inc. · 2006 · 3 generations on15descendants
- K072870Microwave Tissue Coagulation System (MTCS)Foundry Newco X, Inc. · 2008 · 4 generations on11descendants
- K082819Dermatologic Treatment System (DTS) G2Miramar Labs, Inc. · 2009 · 5 generations on10descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K861904 | HS-15M Microwave Surgery Equipment, Microtaze | Cooper Lasersonics, Inc. | 1986 | — |
| −1 | K011676 | Vivawave Microwave System | Vivant Medical, Inc. | 2002 | 1 |
| 0 (this device) | K023311 | Loop Microwave Ablation Probe | Vivant Medical, Inc. | 2003 | — |
| +1 | K032047 | Tri-Loop Microwave Ablation Probe | Vivant Medical, Inc. | 2003 | — |
| +2 | K032702 | Vivatip Microwave Ablation Probe | Vivant Medical, Inc. | 2003 | — |
| +3 | K052919 | Microsulis Tissue Ablation System | Microsulis Americas, Inc. | 2006 | — |
| +4 | K072870 | Microwave Tissue Coagulation System (MTCS) | Foundry Newco X, Inc. | 2008 | — |
| +5 | K082819 | Dermatologic Treatment System (DTS) G2 | Miramar Labs, Inc. | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1986 | 1 | 0 |
| 1996 | 2 | 0 |
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 3 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 5 | 0 |
| 2016 | 2 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 2 | 0 |
| 2025 | 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? (2)
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 |
|---|---|---|---|
| * | K011676 | Vivawave Microwave System | 2002 |
| * | K790187 | Bovie Hand ControlSummary page 1…in cardiac procedures. Predicate Devices VivaWaveTM Microwave System - Vivant Medical, Inc. KO 11676 Bovie Hand Control - Sybron Corp. K790 187 Device Description The device consists of a pre-shaped curved microwave antenna which is contained within a delivery… | 1979 |
What descends from it? (28)
See all 282 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 17 years and passes through 2 companies; a new generation was cleared every 15.7 years on median.
- 1 of the 7 ancestors has a recall of any class.
- Of its descendants, K032047 (Vivant Medical, Inc., 2003) has gone furthest, with 27 descendants of its own.
- 8 other devices also cite its predicate K011676.
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 LoopTM Microwave Ablation Probe is intended for coagulation of soft tissue.
Not for use in cardiac procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K023311 · printed Nov 5, 2026
Cite this page
510(k) Report. “K023311: Loop Microwave Ablation Probe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K023311
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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