510(k) · Cleared

Cleared

Vidamed Series 7205 Electrosurgical Generator

K955035510(k) TraditionalCleared Nov 29, 199527-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

Vidamed, Inc. · GEI Electrosurgical, Cutting & Coagulation & Accessories

Cleared on Nov 29, 1995 after a 27-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 21 later devices descend from it.

Decided: Nov 29, 1995
Review: 27 days
Class: Class II
Product code: GEI
Recalls: None
Predicates: 0

21 later devices descend from it, 2 citing it directly.

This deviceK955035 Vidamed Series 7205 Electrosurgical GeneratorVidamed, Inc. · 1995
Descendant · cites it directly · 19 of its ownK960918 Vidamed Tuna (Transurethral Needle Ablation) SystemVidamed, Inc. · 1996
Descendant · cites it directly · 13 of its ownK963180 Vidamed RF Generator Data RecorderVidamed, Inc. · 1996
Descendant · 2 generations on · 12 of its ownK965061 Vidamed Modedl 7600 RF GeneratorVidamed, Inc. · 1997
Descendant · 2 generations on · 10 of its ownK052413 Tuna System, Models 8909, 8929, 8930, 8934Medtronic Vascular · 2005 · Recalled
Descendant · 3 generations on · 9 of its ownK113380 Prostiva RF Therapy Hand Piece Prostiva RF Therapy RF GeneratorMedtronic, Inc. · 2012 · Recalled

Showing 5 of 21 descendants. See all descendants

Descendants cleared per year

1996high 4 (2002) · low 0 (1998)2026

Most influential descendants

Showing 5 of 21 · See all

K960918Vidamed Tuna (Transurethral Needle Ablation) SystemVidamed, Inc. · 1996 · cites it directly19descendants
K963180Vidamed RF Generator Data RecorderVidamed, Inc. · 1996 · cites it directly13descendants
K965061Vidamed Modedl 7600 RF GeneratorVidamed, Inc. · 1997 · 2 generations on12descendants
K052413Tuna System, Models 8909, 8929, 8930, 8934Medtronic Vascular · 2005 · 2 generations on10descendants
K113380Prostiva RF Therapy Hand Piece Prostiva RF Therapy RF GeneratorMedtronic, Inc. · 2012 · 3 generations on9descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K955035	Vidamed Series 7205 Electrosurgical Generator	Vidamed, Inc.	1995	—
+1	K960918	Vidamed Tuna (Transurethral Needle Ablation) System	Vidamed, Inc.	1996	—
+1	K963180	Vidamed RF Generator Data Recorder	Vidamed, Inc.	1996	—
+2	K965061	Vidamed Modedl 7600 RF Generator	Vidamed, Inc.	1997	—
+2	K052413	Tuna System, Models 8909, 8929, 8930, 8934	Medtronic Vascular	2005	1
+3	K113380	Prostiva RF Therapy Hand Piece Prostiva RF Therapy RF Generator	Medtronic, Inc.	2012	2

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1996	2	0
1997	2	0
1999	1	0
2002	4	0
2004	1	0
2005	1	0
2012	1	0
2015	2	0
2016	1	0
2018	1	0
2019	2	0
2025	2	0
2026	1	0

FIG. 1 — Lineage of K955035, 1995–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), 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

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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (21)

See all 21

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

Number	Device	Applicant	Decided	Descendants
K960918	Vidamed Tuna (Transurethral Needle Ablation) System	Vidamed, Inc.	1996	19
K963180	Vidamed RF Generator Data Recorder	Vidamed, Inc.	1996	13

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?

Of its descendants, K960918 (Vidamed, Inc., 1996) has gone furthest, with 19 descendants of its own.

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	—

https://510kreport.com/device/K955035 · printed Nov 6, 2026

Cite this page

510(k) Report. “K955035: Vidamed Series 7205 Electrosurgical Generator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K955035

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Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026