510(k) · Cleared
ClearedEsg-400 Model WB95051N, Footswitch Double Pedal Model WB50402W, Footswitch Single Pedal Model WB50403W, P-Cord Model Maj
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 Jan 14, 2011 as substantially equivalent to K023886 (Erbe USA, Inc., 2002) and 2 other predicates after a 94-day review. Its family tree reaches back 4 generations to 1991. 12 later devices descend from it.
- Decided
- Jan 14, 2011
- Review
- 94 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K911904 (1991). 12 ancestors in all. 12 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK911904 Models Ues-10 & PSD-10Olympus Corp. · 1991
- 3 generations backK970184 Olympus Ues-20 Electrosurgical System and Its Associated AccessoriesOlympus America, Inc. · 1997
- 2 generations backK023767 Ues-30 Electrosurgical Unit and It's Associated AccessoriesThe Olympus Optical Co. · 2002
- 1 generation backK030194 Xues-41 Endoscopic Electrosurgical UnitThe Olympus Optical Co. · 2003 · Recalled
- This deviceK103032 Esg-400 Model WB95051N, Footswitch Double Pedal Model WB50402W…Olympus Winter & Ibe GmbH · 2011
- Descendant · cites it directly · 11 of its ownK141225 Esg-400, Footswitch Double Pedal, Footswitch Single Pedal, P-CordOlympus Winter & Ibe GmbH · 2014
- Descendant · 2 generations on · 3 of its ownK211838 Ultrasonic Bipolar Generator USG-410 with accessoriesOlympus Medical Systems Corporation · 2021 · Recalled
- Descendant · 2 generations on · 2 of its ownK203682 Electrosurgical Generator ESG-400, Foot Switches, POWERSEAL Curved…Olympus Winter & Ibe GmbH · 2021
- Descendant · 3 generations on · 1 of its ownK212643 POWERSEAL Curved Jaw Sealer and Divider, Double ActionOlympus Surgical Technologies America · 2021 · Recalled
- Descendant · 2 generations on · 1 of its ownK203277 Electrosurgical Generator ESG-410, Foot Switches, PK Cutting ForcepsOlympus Winter & Ibe GmbH · 2021 · Recalled
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K141225Esg-400, Footswitch Double Pedal, Footswitch Single Pedal, P-CordOlympus Winter & Ibe GmbH · 2014 · cites it directly11descendants
- K211838Ultrasonic Bipolar Generator USG-410 with accessoriesOlympus Medical Systems Corporation · 2021 · 2 generations on3descendants
- K203682Electrosurgical Generator ESG-400, Foot Switches, POWERSEAL Curved Jaw Sealer and…Olympus Winter & Ibe GmbH · 2021 · 2 generations on2descendants
- K212643POWERSEAL Curved Jaw Sealer and Divider, Double ActionOlympus Surgical Technologies America · 2021 · 3 generations on1descendant
- K203277Electrosurgical Generator ESG-410, Foot Switches, PK Cutting ForcepsOlympus Winter & Ibe GmbH · 2021 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K911904 | Models Ues-10 & PSD-10 | Olympus Corp. | 1991 | — |
| −3 | K970184 | Olympus Ues-20 Electrosurgical System and Its Associated Accessories | Olympus America, Inc. | 1997 | — |
| −2 | K023767 | Ues-30 Electrosurgical Unit and It's Associated Accessories | The Olympus Optical Co. | 2002 | — |
| −1 | K030194 | Xues-41 Endoscopic Electrosurgical Unit | The Olympus Optical Co. | 2003 | 3 |
| 0 (this device) | 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 | — |
| +2 | K211838 | Ultrasonic Bipolar Generator USG-410 with accessories | Olympus Medical Systems Corporation | 2021 | 13 |
| +2 | K203682 | Electrosurgical Generator ESG-400, Foot Switches, POWERSEAL Curved Jaw Sealer… | Olympus Winter & Ibe GmbH | 2021 | — |
| +3 | K212643 | POWERSEAL Curved Jaw Sealer and Divider, Double Action | Olympus Surgical Technologies America | 2021 | 7 |
| +2 | K203277 | Electrosurgical Generator ESG-410, Foot Switches, PK Cutting Forceps | Olympus Winter & Ibe GmbH | 2021 | 4 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1999 | 3 | 0 |
| 2002 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 2 | 0 |
| 2021 | 4 | 0 |
| 2023 | 2 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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? (3)
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 |
|---|---|---|---|
| * | K023886 | Erbe Vio Esu with Accessories, Model Vio 300 DSummary page 2…Class: 11 Legally Marketed Trade Name 51 0(k) Applicant Predicate Devices: Erbe VIG ESU (Model K023886 Erbe USA, Inc. VIO 300 D) with Accessories… | 2002 |
| * | K060484 | Erbe Vio Esu, Model Vio 300 DSummary page 2…l K023886 Erbe USA, Inc. VIO 300 D) with Accessories Erbe VIO ESU (Model K060484 Erbe USA, Inc. VIO 300 D) XUES-41 K0301 94… | 2006 |
| * | K030194 | Xues-41 Endoscopic Electrosurgical UnitSummary page 2…Erbe VIO ESU (Model K060484 Erbe USA, Inc. VIO 300 D) XUES-41 K0301 94 Olympus Optical Co.Ltd. Device Descrip… | 2003 |
What descends from it? (12)
See all 121 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K141225 | Esg-400, Footswitch Double Pedal, Footswitch Single Pedal, P-Cord | 2014 | 11 |
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 20 years and passes through 4 companies; a new generation was cleared every 5.7 years on median.
- 2 of the 12 ancestors have a recall of any class.
- Of its descendants, K141225 (Olympus Winter & Ibe GmbH, 2014) has gone furthest, with 11 descendants of its own.
- 8 other devices also cite its predicate K023886.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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?
The Olympus ESG-400 electrosurgical unit is intended for cutting and coagulation of tissue in open, laparoscopic and endloscopic surgery in conjunction with electrosurgical accessories and ancillary equipment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103032 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103032: Esg-400 Model WB95051N, Footswitch Double Pedal Model WB50402W, Footswitch Single Pedal Model WB50403W, P-Cord Model Maj.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103032
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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