510(k) · Cleared

Cleared

Vivatip Microwave Ablation Probe

K032702510(k) SpecialCleared Oct 3, 200331-day reviewClass II21 CFR 878.4400

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Vivant Medical, Inc. · GEI Electrosurgical, Cutting & Coagulation & Accessories

Cleared on Oct 3, 2003 as substantially equivalent to K011676 (Vivant Medical, Inc., 2002) and 1 other predicate after a 31-day review. Its family tree reaches back 4 generations to 1986. 26 later devices descend from it.

Decided: Oct 3, 2003
Review: 31 days
Class: Class II
Product code: GEI
Recalls: None
Predicates: 2

Its longest line of descent runs back 4 generations to K861904 (1986). 9 ancestors in all, the oldest K790187 (1979). 26 later devices descend from it, 6 citing it directly.

By dateBy generation

Root · 4 generations backK861904 HS-15M Microwave Surgery Equipment, MicrotazeCooper Lasersonics, Inc. · 1986
3 generations backK011676 Vivawave Microwave SystemVivant Medical, Inc. · 2002 · Recalled
2 generations backK023311 Loop Microwave Ablation ProbeVivant Medical, Inc. · 2003
1 generation backK032047 Tri-Loop Microwave Ablation ProbeVivant Medical, Inc. · 2003
This deviceK032702 Vivatip Microwave Ablation ProbeVivant Medical, Inc. · 2003
Descendant · cites it directly · 15 of its ownK052919 Microsulis Tissue Ablation SystemMicrosulis Americas, Inc. · 2006
Descendant · 2 generations on · 11 of its ownK072870 Microwave Tissue Coagulation System (MTCS)Foundry Newco X, Inc. · 2008
Descendant · 3 generations on · 10 of its ownK082819 Dermatologic Treatment System (DTS) G2Miramar Labs, Inc. · 2009
Descendant · 4 generations on · 5 of its ownK103014 Miradry SystemMiramar Labs, Inc. · 2011 · Recalled
Descendant · cites it directly · 4 of its ownK083157 HS AmicaH.S Hospital Service S.P.A · 2009

Showing 5 of 26 descendants. See all descendants

Descendants cleared per year

2004high 5 (2015) · low 0 (2005)2026

Most influential descendants

Showing 5 of 26 · See all

K052919Microsulis Tissue Ablation SystemMicrosulis Americas, Inc. · 2006 · cites it directly15descendants
K072870Microwave Tissue Coagulation System (MTCS)Foundry Newco X, Inc. · 2008 · 2 generations on11descendants
K082819Dermatologic Treatment System (DTS) G2Miramar Labs, Inc. · 2009 · 3 generations on10descendants
K103014Miradry SystemMiramar Labs, Inc. · 2011 · 4 generations on5descendants
K083157HS AmicaH.S Hospital Service S.P.A · 2009 · cites it directly4descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−4	K861904	HS-15M Microwave Surgery Equipment, Microtaze	Cooper Lasersonics, Inc.	1986	—
−3	K011676	Vivawave Microwave System	Vivant Medical, Inc.	2002	1
−2	K023311	Loop Microwave Ablation Probe	Vivant Medical, Inc.	2003	—
−1	K032047	Tri-Loop Microwave Ablation Probe	Vivant Medical, Inc.	2003	—
0 (this device)	K032702	Vivatip Microwave Ablation Probe	Vivant Medical, Inc.	2003	—
+1	K052919	Microsulis Tissue Ablation System	Microsulis Americas, Inc.	2006	—
+2	K072870	Microwave Tissue Coagulation System (MTCS)	Foundry Newco X, Inc.	2008	—
+3	K082819	Dermatologic Treatment System (DTS) G2	Miramar Labs, Inc.	2009	—
+4	K103014	Miradry System	Miramar Labs, Inc.	2011	2
+1	K083157	HS Amica	H.S Hospital Service S.P.A	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
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

FIG. 1 — Lineage of K032702, 1986–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

Get a 510(k) 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	Applicant	Decided	Recalls
*	K011676	Vivawave Microwave System	Vivant Medical, Inc.	2002	1
*	K032047	Tri-Loop Microwave Ablation Probe	Vivant Medical, Inc.	2003	—

Also cleared against K011676: 8 other devices →

What descends from it? (26)

See all 26

6 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K052919	Microsulis Tissue Ablation System	Microsulis Americas, Inc.	2006	15
K083157	HS Amica	H.S Hospital Service S.P.A	2009	4
K040279	Vivaring Microwave Ablation Probe	Vivant Medical, Inc.	2004	3
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	1
K150019	TheraVision Ultrasound Ablation System and ACOUSTx Applicators	Acoustic Medsystems, Inc.	2016	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 17 years and passes through 2 companies; a new generation was cleared every 10 months on median.
1 of the 9 ancestors has a recall of any class.
Of its descendants, K052919 (Microsulis Americas, Inc., 2006) has gone furthest, with 15 descendants of its own.
8 other devices also cite its predicate K011676.

How does its category compare?

All GEI devices

GEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GEI

52in 2025

2007high 65 (2023) · low 35 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GEI

113in 2025

2007high 183 (2026) · low 51 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · GEI

4in 2025

2007high 51 (2010) · low 1 (2020)2026

Class I (14 since 2007) Class II/III not classified

Adverse event reports per year · GEI

7,592in 2025

2007high 7,897 (2024) · low 2,556 (2008)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 VivaTipM 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/K032702 · printed Nov 4, 2026

Cite this page

510(k) Report. “K032702: Vivatip Microwave Ablation Probe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K032702

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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