510(k) · Cleared
ClearedGyrus Endourology System: Axipolar Resectoscope Electrode
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Gyrus Medical, Ltd. · KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
Cleared on Dec 27, 1999 as substantially equivalent to K990628 (Gyrus Medical, Ltd., 1999) after an 18-day review. Its family tree reaches back 2 generations to 1994. 16 later devices descend from it.
- Decided
- Dec 27, 1999
- Review
- 18 days
- Class
- Class II
- Product code
- KNS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K933002 (1994). 6 ancestors in all. 16 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK933002 Erbotom Icc 350Erbe USA, Inc. · 1994
- 1 generation backK990628 Gyrus Endourology SystemGyrus Medical, Ltd. · 1999
- This deviceK994166 Gyrus Endourology System: Axipolar Resectoscope ElectrodeGyrus Medical, Ltd. · 1999
- 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 · 3 generations on · 3 of its ownK171965 Resection Electrodes with HF cableOlympus Winter & Ibe GmbH · 2017 · Recalled
- Descendant · 3 generations on · 3 of its ownK120567 Gyrus Amci PK Button ElectrodeGyrus Acmi, Inc. · 2012
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 16 · 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
- K171965Resection Electrodes with HF cableOlympus Winter & Ibe GmbH · 2017 · 3 generations on3descendants
- K120567Gyrus Amci PK Button ElectrodeGyrus Acmi, Inc. · 2012 · 3 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K933002 | Erbotom Icc 350 | Erbe USA, Inc. | 1994 | — |
| −1 | K990628 | Gyrus Endourology System | Gyrus Medical, Ltd. | 1999 | — |
| 0 (this device) | K994166 | Gyrus Endourology System: Axipolar Resectoscope Electrode | Gyrus Medical, Ltd. | 1999 | — |
| +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 |
| +3 | K171965 | Resection Electrodes with HF cable | Olympus Winter & Ibe GmbH | 2017 | 1 |
| +3 | K120567 | Gyrus Amci PK Button Electrode | Gyrus Acmi, Inc. | 2012 | — |
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 |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 2 | 0 |
| 2021 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 1 | 0 |
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
What was it cleared against? (1)
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 | Decided |
|---|---|---|---|
| * | K990628 | Gyrus Endourology SystemSummary page 1…sification name: Endoscopic Electrosurgical Unit and Accessories (21 CFR 876.4300) 2, Equivalence Device Premarket Notification Gyrus Axipolar Resectoscope Electrode K990628 3. Device Description The Axipolar Resectoscope Electrode devices described in this 510(k) are sterile, disposable electrodes d… | 1999 |
What descends from it? (16)
See all 162 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 5 years and passes through 2 companies; a new generation was cleared every 5.3 years on median.
- 1 of the 6 ancestors has a recall of any class.
- Of its descendants, K100275 (Olympus Winter & Ibe GmbH, 2010) has gone furthest, with 15 descendants of its own.
- 3 other devices also cite its predicate K990628.
How does its category compare?
All KNS devicesKNS 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
2026 to Oct 25, outlined.
Median 510(k) review, days · KNS
171in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KNS
14in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KNS
1,504in 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, when used with a Gyrus “Axipolar Resectoscope Electrode, 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/K994166 · printed Nov 4, 2026
Cite this page
510(k) Report. “K994166: Gyrus Endourology System: Axipolar Resectoscope Electrode.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K994166
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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