510(k) · Cleared
ClearedOlympus PSD-20 Electrosurgical System and Accessories
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Olympus America, Inc. · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on May 28, 1997 as substantially equivalent to K911904 (Olympus Corp., 1991) after an 85-day review. Its family tree reaches back 1 generation to 1991. 2 later devices descend from it.
- Decided
- May 28, 1997
- Review
- 85 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K911904 (1991). 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK911904 Models Ues-10 & PSD-10Olympus Corp. · 1991
- This deviceK970797 Olympus PSD-20 Electrosurgical System and AccessoriesOlympus America, Inc. · 1997
- Descendant · cites it directly · 0 of its ownK021852 Olympus PSD-20 Electrosurgical System & Its Associated AccessoriesOlympus Optical Co., Ltd. · 2003
- Descendant · cites it directly · 0 of its ownK023280 Olympus PSD-20 Electrosurgical System and Its Associated AccessoriesOlympus Optical Co., Ltd. · 2002
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 |
|---|---|---|---|---|---|
| −1 | K911904 | Models Ues-10 & PSD-10 | Olympus Corp. | 1991 | — |
| 0 (this device) | K970797 | Olympus PSD-20 Electrosurgical System and Accessories | Olympus America, Inc. | 1997 | — |
| +1 | K021852 | Olympus PSD-20 Electrosurgical System & Its Associated Accessories | Olympus Optical Co., Ltd. | 2003 | — |
| +1 | K023280 | Olympus PSD-20 Electrosurgical System and Its Associated Accessories | Olympus Optical Co., Ltd. | 2002 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2003 | 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? (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 |
|---|---|---|---|
| * | K911904 | Models Ues-10 & PSD-10Summary page 1…Coagulation Device and Accessories. 21 CFR 876.4300, Class II Endoscopic Electrosurgical Unit and Accessories. Predicate Devices: Olympus PSD-10 Electrosurgical Unit (K911904) Prepared & Submitted By: Mr. Subhash Patel (Contact Person) Olympus America Inc. Endoscope Division Two Corporate Center Drive… | 1991 |
What descends from it? (2)
2 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?
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?
The Olympus PSD-20 has been intended to cut and coagulate tissues within the gastrointestinal (GI) tract. The PSD-20 is designed to be used in conjunction with the electrosurgical accessories and the designated Olympus endoscopes that are applicable for electrosurgery. The Olympus PSD-20 has been designed for use in medical facilities under the supervision of a trained physician. It has been designed for general and endoscopic electrosurgery (cutting and…
Read the full statement (103 words)
The Olympus PSD-20 has been intended to cut and coagulate tissues within the gastrointestinal (GI) tract. The PSD-20 is designed to be used in conjunction with the electrosurgical accessories and the designated Olympus endoscopes that are applicable for electrosurgery.
The Olympus PSD-20 has been designed for use in medical facilities under the supervision of a trained physician. It has been designed for general and endoscopic electrosurgery (cutting and coagulation) in conjunction with Olympus designated electrosurgical accessories, endoscopes (fiberscopes, videoscopes, and rigid scopes) applicable to electrosurgery, light sources and ancillary equipment. Do not use the instrument for any purpose other than its intended use.
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/K970797 · printed Nov 4, 2026
Cite this page
510(k) Report. “K970797: Olympus PSD-20 Electrosurgical System and Accessories.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K970797
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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