510(k) · Cleared
ClearedPlasma Edge System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Chirurgie Innovation · FAS Electrode, Electrosurgical, Active, Urological
Cleared on May 23, 2017 as substantially equivalent to K994166 (Gyrus Medical, Ltd., 1999) and 1 other predicate after a 200-day review. Its family tree reaches back 7 generations to 1991. 2 later devices descend from it.
- Decided
- May 23, 2017
- Review
- 200 days
- Class
- Class II
- Product code
- FAS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K911904 (1991). 23 ancestors in all, the oldest K903323 (1990). 2 later devices descend from it, 1 citing it directly.
- Root · 7 generations backK911904 Models Ues-10 & PSD-10Olympus Corp. · 1991
- 6 generations backK970184 Olympus Ues-20 Electrosurgical System and Its Associated AccessoriesOlympus America, Inc. · 1997
- 5 generations backK023767 Ues-30 Electrosurgical Unit and It's Associated AccessoriesThe Olympus Optical Co. · 2002
- 4 generations backK030194 Xues-41 Endoscopic Electrosurgical UnitThe Olympus Optical Co. · 2003 · Recalled
- 3 generations backK100275 Working Element, Resection Button Electrode for Plasma Vaporizaton…Olympus Winter & Ibe GmbH · 2010 · Recalled
- 2 generations backK102781 Resection Button Electrode for Plasma Vaporization, HF-Resection…Olympus Winter & Ibe GmbH · 2011 · Recalled
- 1 generation backK120567 Gyrus Amci PK Button ElectrodeGyrus Acmi, Inc. · 2012
- This deviceK163090 Plasma Edge SystemChirurgie Innovation · 2017
- Descendant · cites it directly · 1 of its ownK213135 Plasma Edge resection and vaporization electrodes, Plasma Edge…Chirurgie Innovation · 2022
- Descendant · 2 generations on · 0 of its ownK240504 PLASMA EDGE SystemLamidey Noury Medical · 2024
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K911904 | Models Ues-10 & PSD-10 | Olympus Corp. | 1991 | — |
| −6 | K970184 | Olympus Ues-20 Electrosurgical System and Its Associated Accessories | Olympus America, Inc. | 1997 | — |
| −5 | K023767 | Ues-30 Electrosurgical Unit and It's Associated Accessories | The Olympus Optical Co. | 2002 | — |
| −4 | K030194 | Xues-41 Endoscopic Electrosurgical Unit | The Olympus Optical Co. | 2003 | 3 |
| −3 | K100275 | Working Element, Resection Button Electrode for Plasma Vaporizaton… | Olympus Winter & Ibe GmbH | 2010 | 1 |
| −2 | K102781 | Resection Button Electrode for Plasma Vaporization, HF-Resection Electrode… | Olympus Winter & Ibe GmbH | 2011 | 1 |
| −1 | K120567 | Gyrus Amci PK Button Electrode | Gyrus Acmi, Inc. | 2012 | — |
| 0 (this device) | K163090 | Plasma Edge System | Chirurgie Innovation | 2017 | — |
| +1 | K213135 | Plasma Edge resection and vaporization electrodes, Plasma Edge working… | Chirurgie Innovation | 2022 | — |
| +2 | 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 |
|---|---|---|
| 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? (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 | Decided |
|---|---|---|---|
| * | K994166 | Gyrus Endourology System: Axipolar Resectoscope ElectrodeSummary page 4…Regulation Medical Specialty : Gastroenterology / Urology Device panel 510k Review Panel : General & Plastic Surgery K994166: Axipolar Resectoscope Electrode – manufactured by Legally marketed Gyrus Medical Ltd. predicate devices K120567: Gyrus… | 1999 |
| * | K120567 | Gyrus Amci PK Button ElectrodeSummary page 4…General & Plastic Surgery K994166: Axipolar Resectoscope Electrode – manufactured by Legally marketed Gyrus Medical Ltd. predicate devices K120567: Gyrus ACMI PK Button Electrode – manufactured by Gyrus Medical Ltd. Product Description The Plasma Edge… | 2012 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K213135 | Plasma Edge resection and vaporization electrodes, Plasma Edge working elements, Adaptor… | 2022 | 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?
- The line of descent spans 26 years and passes through 6 companies; a new generation was cleared every 4.9 years on median.
- 4 of the 23 ancestors have a recall of any class.
- Of its descendants, K213135 (Chirurgie Innovation, 2022) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K994166.
How does its category compare?
All FAS devicesFAS Electrode, Electrosurgical, Active, Urological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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 Plasma Edge System single use bipolar resection electrodes are used for the ablation and hemostasis of tissues under endoscopic control, in association with endoscopic accessories. They are intended for endoscopic surgeries with saline irrigation, in the field of urology. The use of the Plasma Edge System is restricted to surgeons, specialized in urological surgery, for specific use in: * Transurethral resection of prostate (TURP) for benign…
Read the full statement (111 words)
The Plasma Edge System single use bipolar resection electrodes are used for the ablation and hemostasis of tissues under endoscopic control, in association with endoscopic accessories. They are intended for endoscopic surgeries with saline irrigation, in the field of urology. The use of the Plasma Edge System is restricted to surgeons, specialized in urological surgery, for specific use in:
* Transurethral resection of prostate (TURP) for benign prostatic hyperplasia
* Transurethral incision of the prostate (TUIP) or bladder neck
* Transurethral resection of bladder tumors (TURBT)
* Cystodiathermy
* Transurethral Vaporization of the prostate (TUVP/TVP) for benign prostatic hyperplasia, and for Transurethral Vaporization of bladder tumors. (MVVS and MVV models only)
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/K163090 · printed Nov 5, 2026
Cite this page
510(k) Report. “K163090: Plasma Edge System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K163090
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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