510(k) · Cleared
ClearedESG-300, APU-300, Pressure Reducer, MAPC Probes
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Olympus Winter & Ibe GmbH · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Apr 26, 2018 as substantially equivalent to K141225 (Olympus Winter & Ibe GmbH, 2014) and 3 other predicates after a 92-day review. Its family tree reaches back 6 generations to 1991.
- Decided
- Apr 26, 2018
- Review
- 92 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 6 generations to K911904 (1991). 21 ancestors in all, the oldest K894762 (1989). No later device cites it as a predicate yet.
- 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 backK103032 Esg-400 Model WB95051N, Footswitch Double Pedal Model WB50402W…Olympus Winter & Ibe GmbH · 2011
- 1 generation backK141225 Esg-400, Footswitch Double Pedal, Footswitch Single Pedal, P-CordOlympus Winter & Ibe GmbH · 2014
- This deviceK180200 ESG-300, APU-300, Pressure Reducer, MAPC ProbesOlympus Winter & Ibe GmbH · 2018
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 | K103032 | Esg-400 Model WB95051N, Footswitch Double Pedal Model WB50402W, Footswitch… | Olympus Winter & Ibe GmbH | 2011 | — |
| −1 | K141225 | Esg-400, Footswitch Double Pedal, Footswitch Single Pedal, P-Cord | Olympus Winter & Ibe GmbH | 2014 | — |
| 0 (this device) | K180200 | ESG-300, APU-300, Pressure Reducer, MAPC Probes | Olympus Winter & Ibe GmbH | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1994 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1999 | 3 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2006 | 2 | 0 |
| 2008 | 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? (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 |
|---|---|---|---|
| * | K141225 | Esg-400, Footswitch Double Pedal, Footswitch Single Pedal, P-CordSummary page 4…Primary Predicate Device Manufacturer 510(k) No ESG-400 Olympus Winter & Ibe GmbH K141225 Table 2.1: Identification of primary predicate device The following secondary predicates for monopolar argon plasma coagulation… | 2014 |
| * | K083452 | Erbe Model Vio 300 D with AccessoriesSummary page 5…Reference Predicate Device Manufacturer 510(k) No the subject device ESG-300 ERBE ESU Model VIO 300 Erbe USA, Inc. K083452 (monopolar argon plasma D with Accessories coagulation modes only) APU-300 with accessories ERBE VIO APC (Model… | 2008 |
| * | K024047 | Erbe Vio Apc with AccessoriesSummary page 5…K083452 (monopolar argon plasma D with Accessories coagulation modes only) APU-300 with accessories ERBE VIO APC (Model 2) Erbe USA, Inc. K024047 with Accessories MAPC probes ERBE APC Integrated Filter Erbe USA, Inc.… | 2003 |
| * | K060183 | Erbe Apc Integrated Filter Probes; Erbe Apc Integrated Filter Probe AdapterSummary page 5…2) Erbe USA, Inc. K024047 with Accessories MAPC probes ERBE APC Integrated Filter Erbe USA, Inc. K060183 Probes and Adapter Table 2.2: Identification of secondary predicate device 2.4 Product Descript… | 2006 |
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 27 years and passes through 4 companies; a new generation was cleared every 5.6 years on median.
- 2 of the 21 ancestors have a recall of any class.
- 5 other devices also cite its predicate K141225.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
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?
ESG-300: The electrosurgical generator ESG-300, in conjunction with electrosurgical accessories and ancillary equipment, is intended for cutting and coagulation of tissue in open surgery, laparoscopic surgery and endoscopic surgery. For monopolar argon plasma coagulation (MAPC) of tissue, the electrosurgical generator is intended to be used with a compatible Olympus argon plasma coagulation unit to deliver ionized argon gas. Accessories: APU-300: The…
Read the full statement (188 words)
ESG-300: The electrosurgical generator ESG-300, in conjunction with electrosurgical accessories and ancillary equipment, is intended for cutting and coagulation of tissue in open surgery, laparoscopic surgery and endoscopic surgery. For monopolar argon plasma coagulation (MAPC) of tissue, the electrosurgical generator is intended to be used with a compatible Olympus argon plasma coagulation unit to deliver ionized argon gas.
Accessories:
APU-300: The argon plasma coagulation unit and its accessories, in conjunction with a compatible Olympus electrosurgical generator and monopolar argon plasma coagulation (MAPC) probes, are intended to deliver ionized argon gas for monopolar argon plasma coagulation of tissue.
Pressure Reducer (accessory of APU-300): The pressure reducers are accessories and must only be used in conjunction with the compatible argon plasma coagulation unit APU-300. Observe the instructions for use of the compatible argon plasma coagulation unit APU-300 regarding: intended use/ contraindications/ user qualifications/ environment of use/ compatible equipment
MAPC probes: The single use and flexible monopolar argon plasma coagulation probes, in conjunction with a compatible Olympus argon plasma coagulation unit and a compatible Olympus electrosurgical generator, are intended to deliver ionized argon gas for monopolar argon plasma coagulation of tissue.
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/K180200 · printed Nov 6, 2026
Cite this page
510(k) Report. “K180200: ESG-300, APU-300, Pressure Reducer, MAPC Probes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K180200
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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