510(k) · Cleared

Cleared

Tuna (Trans Urethra Needle) Office System

K002583510(k) TraditionalCleared Feb 13, 2001179-day reviewClass II21 CFR 876.4300

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

Vidamed, Inc. · KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories)

Cleared on Feb 13, 2001 after a 179-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 16 later devices descend from it.

Decided: Feb 13, 2001
Review: 179 days
Class: Class II
Product code: KNS
Recalls: None
Predicates: 0

16 later devices descend from it, 4 citing it directly.

This deviceK002583 Tuna (Trans Urethra Needle) Office SystemVidamed, Inc. · 2001
Descendant · cites it directly · 10 of its ownK052413 Tuna System, Models 8909, 8929, 8930, 8934Medtronic Vascular · 2005 · Recalled
Descendant · cites it directly · 9 of its ownK113380 Prostiva RF Therapy Hand Piece Prostiva RF Therapy RF GeneratorMedtronic, Inc. · 2012 · Recalled
Descendant · 2 generations on · 8 of its ownK142248 Prostiva RF Therapy Generator, Prostiva RF Therapy Hand Piece…Urologix, Inc. · 2015
Descendant · 2 generations on · 7 of its ownK150786 Rezum SystemNxthera, Inc. · 2015
Descendant · 3 generations on · 5 of its ownK160417 Rezum SystemNxthera, Inc. · 2016 · Recalled

Showing 5 of 16 descendants. See all descendants

Descendants cleared per year

2002high 4 (2002) · low 0 (2003)2026

Most influential descendants

Showing 5 of 16 · See all

K052413Tuna System, Models 8909, 8929, 8930, 8934Medtronic Vascular · 2005 · cites it directly10descendants
K113380Prostiva RF Therapy Hand Piece Prostiva RF Therapy RF GeneratorMedtronic, Inc. · 2012 · cites it directly9descendants
K142248Prostiva RF Therapy Generator, Prostiva RF Therapy Hand Piece, Prostiva RF Therapy…Urologix, Inc. · 2015 · 2 generations on8descendants
K150786Rezum SystemNxthera, Inc. · 2015 · 2 generations on7descendants
K160417Rezum SystemNxthera, Inc. · 2016 · 3 generations on5descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K002583	Tuna (Trans Urethra Needle) Office System	Vidamed, Inc.	2001	—
+1	K052413	Tuna System, Models 8909, 8929, 8930, 8934	Medtronic Vascular	2005	1
+1	K113380	Prostiva RF Therapy Hand Piece Prostiva RF Therapy RF Generator	Medtronic, Inc.	2012	2
+2	K142248	Prostiva RF Therapy Generator, Prostiva RF Therapy Hand Piece, Prostiva RF…	Urologix, Inc.	2015	—
+2	K150786	Rezum System	Nxthera, Inc.	2015	—
+3	K160417	Rezum System	Nxthera, Inc.	2016	1

Descendants by year cleared

Year cleared	Devices	With a Class I recall
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 K002583, 2001–2026Source: 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 KNS? 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 KNS device

#1 K241271 Aqua Medical RF Vapor Ablation Systemscore 17.2 · 20 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? (16)

See all 16

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

Number	Device	Applicant	Decided	Descendants
K052413	Tuna System, Models 8909, 8929, 8930, 8934	Medtronic Vascular	2005	10
K113380	Prostiva RF Therapy Hand Piece Prostiva RF Therapy RF Generator	Medtronic, Inc.	2012	9
K011190	Surx Radiofrequency Electrosurgical Generator System and Accessories (Surx LP System)	Surx, Inc.	2002	3
K021804	Precision Plus Tuna Office System; Presision Tuna Office System; Provu Tuna System	Medtronic Vascular	2002	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?

Of its descendants, K052413 (Medtronic Vascular, 2005) has gone furthest, with 10 descendants of its own.

How does its category compare?

All KNS devices

KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories): FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KNS

11in 2025

2007high 11 (2025) · low 1 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KNS

171in 2025

2007high 252 (2015) · low 30 (2016)2026

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

Recalls per year · KNS

14in 2024

2007high 41 (2021) · low 0 (2010)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · KNS

1,504in 2025

2007high 1,533 (2024) · low 164 (2007)2025

MAUDE reports naming product code KNS, 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	1	—	3	164
2008	3	61	5	587
2009	3	212	2	1,027
2010	4	168	0	908
2011	1	—	2	860
2012	2	—	0	848
2013	2	—	0	449
2014	1	—	0	405
2015	3	252	0	406
2016	3	30	6	457
2017	3	48	1	446
2018	5	62	0	563
2019	7	66	0	668
2020	4	212	0	906
2021	4	139	41	814
2022	3	182	0	913
2023	9	83	0	976
2024	3	198	14	1,533
2025	11	171	0	1,504
2026	2	—	4	—

https://510kreport.com/device/K002583 · printed Nov 6, 2026

Cite this page

510(k) Report. “K002583: Tuna (Trans Urethra Needle) Office System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K002583

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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