510(k) · Cleared
ClearedOlympus PSD-20 Electrosurgical System and Its Associated Accessories
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Olympus Optical Co., Ltd. · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Dec 19, 2002 as substantially equivalent to K970797 (Olympus America, Inc., 1997) and 1 other predicate after a 79-day review. Its family tree reaches back 2 generations to 1991.
- Decided
- Dec 19, 2002
- Review
- 79 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K911904 (1991). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 2 generations backK911904 Models Ues-10 & PSD-10Olympus Corp. · 1991
- 1 generation backK970184 Olympus Ues-20 Electrosurgical System and Its Associated AccessoriesOlympus America, Inc. · 1997
- This deviceK023280 Olympus PSD-20 Electrosurgical System and Its Associated AccessoriesOlympus Optical Co., Ltd. · 2002
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K911904 | Models Ues-10 & PSD-10 | Olympus Corp. | 1991 | — |
| −1 | K970184 | Olympus Ues-20 Electrosurgical System and Its Associated Accessories | Olympus America, Inc. | 1997 | — |
| 0 (this device) | K023280 | Olympus PSD-20 Electrosurgical System and Its Associated Accessories | Olympus Optical Co., Ltd. | 2002 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 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 GEI? 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 GEI device
- #1 K231790 The InMode System with the Morpheus8 Applicatorsscore 32.7 · 21 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 |
|---|---|---|---|
| * | K970797 | Olympus PSD-20 Electrosurgical System and AccessoriesSummary page 1…acteristics or specification. I Model Name 510(k) Applicant Olympus PSD-20 Electrosurgical K970797 Olympus Optical Co., Ltd. Unit and its associated accessories (For GI application ) 0… | 1997 |
| * | K970184 | Olympus Ues-20 Electrosurgical System and Its Associated AccessoriesSummary page 1…Olympus Optical Co., Ltd. Unit and its associated accessories (For GI application ) 0Iympus UES-20 ElectrosurgicaI Units K970184 Olympus Optical Co., Ltd. and its associated accessories (For urology application) D.… | 1997 |
What descends from it?
No later submission names this one as a predicate yet.
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 11 years and passes through 3 companies; a new generation was cleared every 5.7 years on median.
- None of the 3 ancestors has a recall.
- 1 other device also cites its predicate K970797.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GEI
52in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GEI
113in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GEI
4in 2025
Class I (14 since 2007) Class II/III not classified
Adverse event reports per year · GEI
7,592in 2025
MAUDE reports naming product code GEI, 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 | 50 | 51 | 21 | 2,795 |
| 2008 | 61 | 71 | 19 | 2,556 |
| 2009 | 42 | 130 | 27 | 3,591 |
| 2010 | 46 | 109 | 51 | 3,377 |
| 2011 | 35 | 135 | 32 | 4,463 |
| 2012 | 39 | 133 | 30 | 5,216 |
| 2013 | 48 | 136 | 13 | 4,897 |
| 2014 | 49 | 103 | 3 | 4,908 |
| 2015 | 47 | 123 | 4 | 4,936 |
| 2016 | 64 | 108 | 3 | 5,616 |
| 2017 | 52 | 72 | 2 | 6,073 |
| 2018 | 47 | 93 | 6 | 6,545 |
| 2019 | 48 | 93 | 5 | 7,067 |
| 2020 | 59 | 105 | 1 | 6,490 |
| 2021 | 46 | 146 | 6 | 6,354 |
| 2022 | 55 | 150 | 49 | 6,103 |
| 2023 | 65 | 104 | 27 (4) | 7,176 |
| 2024 | 59 | 125 | 22 (10) | 7,897 |
| 2025 | 52 | 113 | 4 | 7,592 |
| 2026 | 43 | 183 | 8 | — |
What is it indicated for?
This instrument has been designed to be used with Olympus recommended Electrosurgical accessories, Endoscope, Light Source and other ancillary equipment for flexible cystoscopic treatment (cutting and coagulating) including:
- Hemostasis of superficial bleeding
- Treatment of bladder tumors
- Treatment of stenosis inside urinary tract.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K023280 · printed Nov 6, 2026
Cite this page
510(k) Report. “K023280: Olympus PSD-20 Electrosurgical System and Its Associated Accessories.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023280
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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