510(k) · Cleared

Cleared

Usa Elite System Vaportrode Vaporization Electrode and Vaportome Resection Electrode

K973820510(k) TraditionalCleared May 12, 1998217-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

Circon Corp. · FAS Electrode, Electrosurgical, Active, Urological

Cleared on May 12, 1998 after a 217-day review. The FDA summary names its predicate without a number. 24 later devices descend from it.

Decided: May 12, 1998
Review: 217 days
Class: Class II
Product code: FAS
Recalls: None
Predicates: 0

24 later devices descend from it, 5 citing it directly.

This deviceK973820 Usa Elite System Vaportrode Vaporization Electrode and Vaportome…Circon Corp. · 1998
Descendant · cites it directly · 15 of its ownK100275 Working Element, Resection Button Electrode for Plasma Vaporizaton…Olympus Winter & Ibe GmbH · 2010 · Recalled
Descendant · 2 generations on · 5 of its ownK152092 Resection ElectrodesOlympus Winter & Ibe GmbH · 2015 · Recalled
Descendant · 2 generations on · 5 of its ownK102781 Resection Button Electrode for Plasma Vaporization, HF-Resection…Olympus Winter & Ibe GmbH · 2011 · Recalled
Descendant · cites it directly · 4 of its ownK093181 Gyrus Acmi PK Button ElectrodeGyrus Acmi, Inc. · 2010
Descendant · 3 generations on · 3 of its ownK171965 Resection Electrodes with HF cableOlympus Winter & Ibe GmbH · 2017 · Recalled

Showing 5 of 24 descendants. See all descendants

Descendants cleared per year

1999high 2 (2010) · low 0 (2000)2026

Most influential descendants

Showing 5 of 24 · See all

K100275Working Element, Resection Button Electrode for Plasma Vaporizaton, HF-Resection…Olympus Winter & Ibe GmbH · 2010 · cites it directly15descendants
K152092Resection ElectrodesOlympus Winter & Ibe GmbH · 2015 · 2 generations on5descendants
K102781Resection Button Electrode for Plasma Vaporization, HF-Resection Electrode Rollers and…Olympus Winter & Ibe GmbH · 2011 · 2 generations on5descendants
K093181Gyrus Acmi PK Button ElectrodeGyrus Acmi, Inc. · 2010 · cites it directly4descendants
K171965Resection Electrodes with HF cableOlympus Winter & Ibe GmbH · 2017 · 3 generations on3descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K973820	Usa Elite System Vaportrode Vaporization Electrode and Vaportome Resection…	Circon Corp.	1998	—
+1	K100275	Working Element, Resection Button Electrode for Plasma Vaporizaton…	Olympus Winter & Ibe GmbH	2010	1
+2	K152092	Resection Electrodes	Olympus Winter & Ibe GmbH	2015	1
+2	K102781	Resection Button Electrode for Plasma Vaporization, HF-Resection Electrode…	Olympus Winter & Ibe GmbH	2011	1
+1	K093181	Gyrus Acmi PK Button Electrode	Gyrus Acmi, Inc.	2010	—
+3	K171965	Resection Electrodes with HF cable	Olympus Winter & Ibe GmbH	2017	1

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1999	1	0
2003	1	0
2005	1	0
2006	1	0
2007	1	0
2010	2	0
2011	1	0
2012	2	0
2013	1	0
2015	1	0
2016	2	0
2017	2	0
2019	1	0
2021	2	0
2022	1	0
2023	2	0
2024	1	0
2025	1	0

FIG. 1 — Lineage of K973820, 1998–2025Source: 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 FAS? 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 FAS device

#1 K250522 Multi4 Systemscore 11.4 · 7 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? (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
*	—	American Cystoscope Makers, Inc. Grooved Roller Electrodes Named without a submission number			—
*	—	American Cystoscope Makers, Inc. Resectoscope Cutting Loops Named without a submission number			—

What descends from it? (24)

See all 24

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

Number	Device	Applicant	Decided	Descendants
K100275	Working Element, Resection Button Electrode for Plasma Vaporizaton, HF-Resection…	Olympus Winter & Ibe GmbH	2010	15
K093181	Gyrus Acmi PK Button Electrode	Gyrus Acmi, Inc.	2010	4
K031001	Acmi Vista CTR Bipolar Loop Electrode	Acmi Corporation	2003	3
K991314	Coaguloop	American Medical Systems, Inc.	1999	2
K050910	Roei Working Element and Roel Cutting Loops	Roei Medical Technologies, Ltd.	2005	1

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, K100275 (Olympus Winter & Ibe GmbH, 2010) has gone furthest, with 15 descendants of its own.

How does its category compare?

All FAS devices

FAS Electrode, Electrosurgical, Active, Urological: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FAS

2in 2025

2007high 3 (2010) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FAS

150in 2010

2007high 150 (2010)2026

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

Recalls per year · FAS

1in 2023

2007high 4 (2021) · low 0 (2007)2026

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

Adverse event reports per year · FAS

395in 2025

2007high 395 (2025) · low 6 (2007)2025

MAUDE reports naming product code FAS, 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	0	—	0	6
2008	0	—	0	13
2009	0	—	0	9
2010	3	150	0	25
2011	1	—	0	33
2012	2	—	0	30
2013	0	—	0	48
2014	0	—	0	52
2015	1	—	0	82
2016	1	—	2	69
2017	2	—	0	121
2018	0	—	0	70
2019	0	—	0	61
2020	0	—	0	100
2021	2	—	4	102
2022	1	—	0	147
2023	0	—	1	329
2024	1	—	0	310
2025	2	—	0	395
2026	0	—	0	—

What is it indicated for?

Circon ACMI's USA Elite System™ VaporTrode™ Vaporization Electrodes and VaporTome™ Resection Electrodes are indicated for use in urology for cutting, coagulation, and vaporization of soft tissue, including prostatic and bladder tissue and the treatment of benign prostatic hyperplasia (BPH) and bladder cancer.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K973820 · printed Nov 6, 2026

Cite this page

510(k) Report. “K973820: Usa Elite System Vaportrode Vaporization Electrode and Vaportome Resection Electrode.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K973820

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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