510(k) · Cleared
ClearedGyrus Amci PK Button Electrode
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Gyrus Acmi, Inc. · FAS Electrode, Electrosurgical, Active, Urological
Cleared on Jun 20, 2012 as substantially equivalent to K093181 (Gyrus Acmi, Inc., 2010) and 2 other predicates after a 114-day review. Its family tree reaches back 6 generations to 1991. 3 later devices descend from it.
- Decided
- Jun 20, 2012
- Review
- 114 days
- Class
- Class II
- Product code
- FAS
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 6 generations to K911904 (1991). 22 ancestors in all, the oldest K903323 (1990). 3 later devices descend from it, 1 citing it directly.
- Root · 6 generations backK911904 Models Ues-10 & PSD-10Olympus Corp. · 1991
- 5 generations backK970184 Olympus Ues-20 Electrosurgical System and Its Associated AccessoriesOlympus America, Inc. · 1997
- 4 generations backK023767 Ues-30 Electrosurgical Unit and It's Associated AccessoriesThe Olympus Optical Co. · 2002
- 3 generations backK030194 Xues-41 Endoscopic Electrosurgical UnitThe Olympus Optical Co. · 2003 · Recalled
- 2 generations backK100275 Working Element, Resection Button Electrode for Plasma Vaporizaton…Olympus Winter & Ibe GmbH · 2010 · Recalled
- 1 generation backK102781 Resection Button Electrode for Plasma Vaporization, HF-Resection…Olympus Winter & Ibe GmbH · 2011 · Recalled
- This deviceK120567 Gyrus Amci PK Button ElectrodeGyrus Acmi, Inc. · 2012
- Descendant · cites it directly · 2 of its ownK163090 Plasma Edge SystemChirurgie Innovation · 2017
- Descendant · 2 generations on · 1 of its ownK213135 Plasma Edge resection and vaporization electrodes, Plasma Edge…Chirurgie Innovation · 2022
- Descendant · 3 generations on · 0 of its ownK240504 PLASMA EDGE SystemLamidey Noury Medical · 2024
Most influential descendants
Showing 3 of 3 · See all- K163090Plasma Edge SystemChirurgie Innovation · 2017 · cites it directly2descendants
- K213135Plasma Edge resection and vaporization electrodes, Plasma Edge working elements, Adaptor…Chirurgie Innovation · 2022 · 2 generations on1descendant
- K240504PLASMA EDGE SystemLamidey Noury Medical · 2024 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K911904 | Models Ues-10 & PSD-10 | Olympus Corp. | 1991 | — |
| −5 | K970184 | Olympus Ues-20 Electrosurgical System and Its Associated Accessories | Olympus America, Inc. | 1997 | — |
| −4 | K023767 | Ues-30 Electrosurgical Unit and It's Associated Accessories | The Olympus Optical Co. | 2002 | — |
| −3 | K030194 | Xues-41 Endoscopic Electrosurgical Unit | The Olympus Optical Co. | 2003 | 3 |
| −2 | K100275 | Working Element, Resection Button Electrode for Plasma Vaporizaton… | Olympus Winter & Ibe GmbH | 2010 | 1 |
| −1 | K102781 | Resection Button Electrode for Plasma Vaporization, HF-Resection Electrode… | Olympus Winter & Ibe GmbH | 2011 | 1 |
| 0 (this device) | K120567 | Gyrus Amci PK Button Electrode | Gyrus Acmi, Inc. | 2012 | — |
| +1 | K163090 | Plasma Edge System | Chirurgie Innovation | 2017 | — |
| +2 | K213135 | Plasma Edge resection and vaporization electrodes, Plasma Edge working… | Chirurgie Innovation | 2022 | — |
| +3 | K240504 | PLASMA EDGE System | Lamidey Noury Medical | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1994 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 4 | 0 |
| 2000 | 3 | 0 |
| 2003 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2022 | 1 | 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 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
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K093181 | Gyrus Acmi PK Button ElectrodeSummary page 2…Cyrus ACMI, Inc. June 4, 2012 136 Turnpike Road Southborough, MA 01772 Predicate Devices Gyrus ACMI PK Button Electrode (K09318 1) - Existing design Olympus HF-Resection Electrodes (1(102781) - Existing design /desired indications Gyrus ACMI SuperPulse System… | 2010 |
| * | K102781 | Resection Button Electrode for Plasma Vaporization, HF-Resection Electrode Rollers and…Summary page 2…he system for optimal safe performance with the Gymus AGMI PlC® Button Electrode. This is the identical technology used in the predicate devices, including (K(093181 and K10278 1). Like the predicate K093181, and K(102781 the distal tip of the electrode is a Stainless Steel 304 button measuring 3.16mm in d… | 2011 |
| * | K100816 | PK Superpulse Sysem Generator Model 744000Summary page 2…s ACMI PK Button Electrode (K09318 1) - Existing design Olympus HF-Resection Electrodes (1(102781) - Existing design /desired indications Gyrus ACMI SuperPulse System (1(100816) - Common generator Intended Use The Gyrus ACMI PlC® Button Electrode is a bipolar instrument intended for use in urological ele… | 2010 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K163090 | Plasma Edge System | 2017 | 2 |
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 21 years and passes through 5 companies; a new generation was cleared every 5.6 years on median.
- 4 of the 22 ancestors have a recall of any class.
- Of its descendants, K163090 (Chirurgie Innovation, 2017) has gone furthest, with 2 descendants of its own.
How does its category compare?
All FAS devicesFAS Electrode, Electrosurgical, Active, Urological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · FAS
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FAS
150in 2010
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FAS
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FAS
395in 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?
The Gyrus AGMI PK® Button Electrode is a bipolar instrument intended for use in urological electrosurgical procedures involving the ablation or removal of soft tissue and where associated hemnostasis is required. The specific urological indication fdr the PK@ Button device is Transurethral Vaporization of the prostate (TIJVP/TVP) fdr benign prostatic hypertrophy, and for Transurethral Vaporization of bladder tumors. The PK&~ Button is not to be used to resect tissue.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120567 · printed Nov 6, 2026
Cite this page
510(k) Report. “K120567: Gyrus Amci PK Button Electrode.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K120567
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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