510(k) · Cleared
ClearedGyrus Acmi 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 Feb 24, 2010 as substantially equivalent to K031085 (Gyrus Medical, Inc., 2003) and 3 other predicates after a 139-day review. Its family tree reaches back 2 generations to 1994. 4 later devices descend from it.
- Decided
- Feb 24, 2010
- Review
- 139 days
- Class
- Class II
- Product code
- FAS
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 2 generations to K933002 (1994). 12 ancestors in all, the oldest K903323 (1990). 4 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK933002 Erbotom Icc 350Erbe USA, Inc. · 1994
- 1 generation backK990628 Gyrus Endourology SystemGyrus Medical, Ltd. · 1999
- This deviceK093181 Gyrus Acmi PK Button ElectrodeGyrus Acmi, Inc. · 2010
- Descendant · cites it directly · 3 of its ownK120567 Gyrus Amci PK Button ElectrodeGyrus Acmi, Inc. · 2012
- Descendant · 2 generations on · 2 of its ownK163090 Plasma Edge SystemChirurgie Innovation · 2017
- Descendant · 3 generations on · 1 of its ownK213135 Plasma Edge resection and vaporization electrodes, Plasma Edge…Chirurgie Innovation · 2022
- Descendant · 4 generations on · 0 of its ownK240504 PLASMA EDGE SystemLamidey Noury Medical · 2024
Most influential descendants
Showing 4 of 4 · See all- K120567Gyrus Amci PK Button ElectrodeGyrus Acmi, Inc. · 2012 · cites it directly3descendants
- K163090Plasma Edge SystemChirurgie Innovation · 2017 · 2 generations on2descendants
- K213135Plasma Edge resection and vaporization electrodes, Plasma Edge working elements, Adaptor…Chirurgie Innovation · 2022 · 3 generations on1descendant
- K240504PLASMA EDGE SystemLamidey Noury Medical · 2024 · 4 generations on0descendants
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) | K093181 | Gyrus Acmi PK Button Electrode | Gyrus Acmi, Inc. | 2010 | — |
| +1 | K120567 | Gyrus Amci PK Button Electrode | Gyrus Acmi, Inc. | 2012 | — |
| +2 | K163090 | Plasma Edge System | Chirurgie Innovation | 2017 | — |
| +3 | K213135 | Plasma Edge resection and vaporization electrodes, Plasma Edge working… | Chirurgie Innovation | 2022 | — |
| +4 | K240504 | PLASMA EDGE System | Lamidey Noury Medical | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 3 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 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? (4)
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 |
|---|---|---|---|
| * | K031085 | Gyrus Plasmakinetic Superpulse System (Generator, Accessories)Summary page 2…6, 2009. Southborough, MA 01772 Predicate Devices SuperSect® & SuperLoop(g Electrodes, Gyrms PlasmaKinelticTm SuperPulse®D System K03 1085 The Gymus (ACM!) Endourology System K990628 The Circon ACMI USA Elite System Tm Vaporiz… | 2003 |
| * | K990628 | Gyrus Endourology SystemSummary page 2…des, Gyrms PlasmaKinelticTm SuperPulse®D System K03 1085 The Gymus (ACM!) Endourology System K990628 The Circon ACMI USA Elite System Tm Vaporization Electrode and VaporTomeTm Resection Electrode… | 1999 |
| * | K973820 | Usa Elite System Vaportrode Vaporization Electrode and Vaportome Resection ElectrodeSummary page 2…K990628 The Circon ACMI USA Elite System Tm Vaporization Electrode and VaporTomeTm Resection Electrode K973820 Olympus TURis Button (Resectoscope loops) K903323 Intended Use The Gyrus ACMI PK® Button Ele… | 1998 |
| * | K903323 | Resectoscope LoopsSummary page 2…trode and VaporTomeTm Resection Electrode K973820 Olympus TURis Button (Resectoscope loops) K903323 Intended Use The Gyrus ACMI PK® Button Electrode is a bipolar instrument intended for use in urological surgical procedures invo… | 1990 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K120567 | Gyrus Amci PK Button Electrode | 2012 | 3 |
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 16 years and passes through 3 companies; a new generation was cleared every 10.7 years on median.
- 1 of the 12 ancestors has a recall of any class.
- Of its descendants, K120567 (Gyrus Acmi, Inc., 2012) has gone furthest, with 3 descendants of its own.
- 6 other devices also cite its predicate K031085.
How does its category compare?
All FAS devicesFAS Electrode, Electrosurgical, Active, Urological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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 ACMI PK® Button Electrode is a bipolar instrument intended for use in urological surgical procedures involving the ablation or removal of soft tissue and where associated hemostasis is required. The specific urological indication for the PK® Button is transurethral electrovaporization of the prostate (TUVP/TVP) for benign prostatic hypertrophy only. The PK® Button is not to be used to resect tissue.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K093181 · printed Nov 6, 2026
Cite this page
510(k) Report. “K093181: Gyrus Acmi 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/K093181
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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