510(k) · Cleared

Cleared

Gyrus Endourology System

K990628510(k) TraditionalCleared Jun 29, 1999124-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

Gyrus Medical, Ltd. · KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories)

Cleared on Jun 29, 1999 as substantially equivalent to K962482 (Gynecare, Inc., 1996) and 4 other predicates after a 124-day review. Its family tree reaches back 1 generation to 1994. 52 later devices descend from it.

Decided: Jun 29, 1999
Review: 124 days
Class: Class II
Product code: KNS
Recalls: None
Predicates: 5

Its longest line of descent runs back 1 generation to K933002 (1994). 5 ancestors in all. 52 later devices descend from it, 4 citing it directly.

By dateBy generation

Root · 1 generation backK933002 Erbotom Icc 350Erbe USA, Inc. · 1994
This deviceK990628 Gyrus Endourology SystemGyrus Medical, Ltd. · 1999
Descendant · cites it directly · 49 of its ownK030194 Xues-41 Endoscopic Electrosurgical UnitThe Olympus Optical Co. · 2003 · Recalled
Descendant · 2 generations on · 22 of its ownK100816 PK Superpulse Sysem Generator Model 744000Gyrus Acmi, Inc. · 2010
Descendant · 3 generations on · 16 of its ownK110268 Forcetriad Electrosurgical GeneratorCovidien Lp, Formerly Know AS Valleylab, A Divison · 2011
Descendant · cites it directly · 16 of its ownK994166 Gyrus Endourology System: Axipolar Resectoscope ElectrodeGyrus Medical, Ltd. · 1999
Descendant · 2 generations on · 15 of its ownK100275 Working Element, Resection Button Electrode for Plasma Vaporizaton…Olympus Winter & Ibe GmbH · 2010 · Recalled

Showing 5 of 52 descendants. See all descendants

Descendants cleared per year

1999high 6 (2021) · low 0 (2000)2026

Most influential descendants

Showing 5 of 52 · See all

K030194Xues-41 Endoscopic Electrosurgical UnitThe Olympus Optical Co. · 2003 · cites it directly49descendants
K100816PK Superpulse Sysem Generator Model 744000Gyrus Acmi, Inc. · 2010 · 2 generations on22descendants
K110268Forcetriad Electrosurgical GeneratorCovidien Lp, Formerly Know AS Valleylab, A Divison · 2011 · 3 generations on16descendants
K994166Gyrus Endourology System: Axipolar Resectoscope ElectrodeGyrus Medical, Ltd. · 1999 · cites it directly16descendants
K100275Working Element, Resection Button Electrode for Plasma Vaporizaton, HF-Resection…Olympus Winter & Ibe GmbH · 2010 · 2 generations on15descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K933002	Erbotom Icc 350	Erbe USA, Inc.	1994	—
0 (this device)	K990628	Gyrus Endourology System	Gyrus Medical, Ltd.	1999	—
+1	K030194	Xues-41 Endoscopic Electrosurgical Unit	The Olympus Optical Co.	2003	3
+2	K100816	PK Superpulse Sysem Generator Model 744000	Gyrus Acmi, Inc.	2010	—
+3	K110268	Forcetriad Electrosurgical Generator	Covidien Lp, Formerly Know AS Valleylab, A Divison	2011	—
+1	K994166	Gyrus Endourology System: Axipolar Resectoscope Electrode	Gyrus Medical, Ltd.	1999	—
+2	K100275	Working Element, Resection Button Electrode for Plasma Vaporizaton…	Olympus Winter & Ibe GmbH	2010	1

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1996	1	0
1997	1	0
1999	2	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1999	1	0
2003	1	0
2005	1	0
2010	3	0
2011	3	0
2012	2	0
2013	1	0
2014	1	0
2015	3	0
2016	3	0
2017	4	0
2018	4	0
2019	1	0
2021	6	0
2022	4	0
2023	5	0
2024	4	0
2025	3	0
2026	2	0

FIG. 1 — Lineage of K990628, 1994–2026Source: 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 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

Get a 510(k) Report

What was it cleared against? (5)

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
*	K962482	Scuba System Summary page 1 …stem Classification name: Endoscopic Electrosurgical Unit and Accessories (21 CFR 876.4300) Equivalence Device Premarket Notification Scuba (Gynecare Versapoint™) System K962482 Scuba (Gynecare Versapoint™) System G-VAP Electrode K982738 Gyrus Hysteroscopic Resectoscope K982771 Erbe ERBOTOM ICC 350 K933002…	Gynecare, Inc.	1996	1
*	K982738	Versapoint Electrosurgery System (Scuba) Cleared while this submission was under review Summary page 1 …d Accessories (21 CFR 876.4300) Equivalence Device Premarket Notification Scuba (Gynecare Versapoint™) System K962482 Scuba (Gynecare Versapoint™) System G-VAP Electrode K982738 Gyrus Hysteroscopic Resectoscope K982771 Erbe ERBOTOM ICC 350 K933002 COMEG Urological Electrosurgical Equipment ’ K971881 Devic…	Gynecare, Inc.	1999	—
*	K982771	Gyrus Hysteroscopic Resectoscope Summary page 1 …ce Device Premarket Notification Scuba (Gynecare Versapoint™) System K962482 Scuba (Gynecare Versapoint™) System G-VAP Electrode K982738 Gyrus Hysteroscopic Resectoscope K982771 Erbe ERBOTOM ICC 350 K933002 COMEG Urological Electrosurgical Equipment ’ K971881 Device Description The Gyrus Endourology Syst…	Gyrus Medical, Ltd.	1999	—
*	K933002	Erbotom Icc 350 Summary page 1 …ion Scuba (Gynecare Versapoint™) System K962482 Scuba (Gynecare Versapoint™) System G-VAP Electrode K982738 Gyrus Hysteroscopic Resectoscope K982771 Erbe ERBOTOM ICC 350 K933002 COMEG Urological Electrosurgical Equipment ’ K971881 Device Description The Gyrus Endourology System is comprised of four key c…	Erbe USA, Inc.	1994	—
*	K971881	Comeg Resectoscope and Laser-Resectoscope Working… Summary page 1 …(Gynecare Versapoint™) System G-VAP Electrode K982738 Gyrus Hysteroscopic Resectoscope K982771 Erbe ERBOTOM ICC 350 K933002 COMEG Urological Electrosurgical Equipment ’ K971881 Device Description The Gyrus Endourology System is comprised of four key components: the Electrode, the Connector Cable, an Axi…	Comeg Endoscopy	1997	—

Also cleared against K962482: 2 other devices →

What descends from it? (52)

See all 52

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

Number	Device	Applicant	Decided	Descendants
K030194	Xues-41 Endoscopic Electrosurgical Unit	The Olympus Optical Co.	2003	49
K994166	Gyrus Endourology System: Axipolar Resectoscope Electrode	Gyrus Medical, Ltd.	1999	16
K093181	Gyrus Acmi PK Button Electrode	Gyrus Acmi, Inc.	2010	4
K122716	Plasmatrode Saline Safe Tur Electrode	Cook Ireland, Ltd.	2013	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?

1 of the 5 ancestors has a recall of any class.
Of its descendants, K030194 (The Olympus Optical Co., 2003) has gone furthest, with 49 descendants of its own.
2 other devices also cite its predicate K962482.

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	—

What is it indicated for?

The Gyrus Endourology System is a radio frequency bipolar electrosurgical device system intended for use in urological surgical procedures involving the ablation or removal of soft tissue and where associated hemostasis is required. The specific urological indications where the system can be used are in transurethral prostatectomy (TURP) for benign prostatic hypertrophy, transurethral incision of the prostate (TUIP) or bladder neck, resection of bladder tumors and in cystodiathermy.

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/K990628 · printed Nov 4, 2026

Cite this page

510(k) Report. “K990628: Gyrus Endourology System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K990628

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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