510(k) · Cleared
Recalled · Class II · 2025Electrosurgical Generator ESG-410 and Accessories (WA91327U, WA91327W), Accessories: Foot switches (WA91311W, WA91321W)
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 Aug 18, 2023 as substantially equivalent to K203277 (Olympus Winter & Ibe GmbH, 2021) and 1 other predicate after a 63-day review. Its family tree reaches back 16 generations to 1994. It has been recalled 2 times.
- Decided
- Aug 18, 2023
- Review
- 63 days
- Class
- Class II
- Product code
- GEI
- Recalls
- 2
- Predicates
- 2
Its longest line of descent runs back 16 generations to K936109 (1994). 169 ancestors in all, the oldest K800617 (1980). No later device cites it as a predicate yet.
- Root · 16 generations backK936109 Sharplan Model 1120 CO2 Surgical LaserSharplan Lasers, Inc. · 1994
- 12 generations between
- 3 generations backK151743 THUNDERBEAT Open Fine JawOlympus Medical Systems Corp. · 2016
- 2 generations backK192103 Thunderbeat Open Fine Jaw Type X Hand InstrumentOlympus Medical Systems Corp. · 2020
- 1 generation backK211838 Ultrasonic Bipolar Generator USG-410 with accessoriesOlympus Medical Systems Corporation · 2021 · Recalled
- This deviceK231777 Electrosurgical Generator ESG-410 and Accessories (WA91327U…Olympus Winter & Ibe GmbH · 2023
Show all 16 generations
- Root · 16 generations backK936109 Sharplan Model 1120 CO2 Surgical LaserSharplan Lasers, Inc. · 1994
- 15 generations backK960521 Sharplan Lasers, Inc. Silktouch Flash ScannerSharplan Lasers, Inc. · 1996
- 14 generations backK963339 Coherent Ultrapulse CO2 Surgical LasersCoherent Medical Group · 1997
- 13 generations backK974789 Coherent Ultrapulse S Series CO2 Surgical Lasers Model C and LLumenis, Inc. · 1998
- 12 generations backK990947 Modified Versapulse Select Single Wavelength, HO: Yag and Dual…Lumenis, Inc. · 1999
- 11 generations backK011703 Lumenis Versapulse Powersuite Holmium (HO:Yag) and Dual Wavelength…Lumenis · 2001 · Recalled
- 10 generations backK014290 Entec Plasma WandsArthrocare Corp. · 2002
- 9 generations backK021364 Modification to Entec Plasma WandsArthrocare Corp. · 2002
- 8 generations backK030108 Arthrocare Ent Coblator Surgery SystemArthrocare Corp. · 2003 · Recalled
- 7 generations backK033257 Arthrocare Ent Plasma WandsArthrocare Corp. · 2003
- 6 generations backK063538 Arthrocare Controller (System 2000 and 8000), Arthrocare Patient…Arthrocare Corp. · 2006
- 5 generations backK070374 Arthrocare Ent Plasma WandArthrocare Corp. · 2007 · Recalled
- 4 generations backK100597 Harmonic Focus ShearsEthicon Endo-Surgery, LLC · 2010
- 3 generations backK151743 THUNDERBEAT Open Fine JawOlympus Medical Systems Corp. · 2016
- 2 generations backK192103 Thunderbeat Open Fine Jaw Type X Hand InstrumentOlympus Medical Systems Corp. · 2020
- 1 generation backK211838 Ultrasonic Bipolar Generator USG-410 with accessoriesOlympus Medical Systems Corporation · 2021 · Recalled
- This deviceK231777 Electrosurgical Generator ESG-410 and Accessories (WA91327U…Olympus Winter & Ibe GmbH · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −16 | K936109 | Sharplan Model 1120 CO2 Surgical Laser | Sharplan Lasers, Inc. | 1994 | — |
| −15 | K960521 | Sharplan Lasers, Inc. Silktouch Flash Scanner | Sharplan Lasers, Inc. | 1996 | — |
| −14 | K963339 | Coherent Ultrapulse CO2 Surgical Lasers | Coherent Medical Group | 1997 | — |
| −13 | K974789 | Coherent Ultrapulse S Series CO2 Surgical Lasers Model C and L | Lumenis, Inc. | 1998 | — |
| −12 | K990947 | Modified Versapulse Select Single Wavelength, HO: Yag and Dual Wavelength, HO… | Lumenis, Inc. | 1999 | — |
| −11 | K011703 | Lumenis Versapulse Powersuite Holmium (HO:Yag) and Dual Wavelength… | Lumenis | 2001 | 2 |
| −10 | K014290 | Entec Plasma Wands | Arthrocare Corp. | 2002 | — |
| −9 | K021364 | Modification to Entec Plasma Wands | Arthrocare Corp. | 2002 | — |
| −8 | K030108 | Arthrocare Ent Coblator Surgery System | Arthrocare Corp. | 2003 | 1 |
| −7 | K033257 | Arthrocare Ent Plasma Wands | Arthrocare Corp. | 2003 | — |
| −6 | K063538 | Arthrocare Controller (System 2000 and 8000), Arthrocare Patient Cable, Foot… | Arthrocare Corp. | 2006 | — |
| −5 | K070374 | Arthrocare Ent Plasma Wand | Arthrocare Corp. | 2007 | 1 |
| −4 | K100597 | Harmonic Focus Shears | Ethicon Endo-Surgery, LLC | 2010 | — |
| −3 | K151743 | THUNDERBEAT Open Fine Jaw | Olympus Medical Systems Corp. | 2016 | — |
| −2 | K192103 | Thunderbeat Open Fine Jaw Type X Hand Instrument | Olympus Medical Systems Corp. | 2020 | — |
| −1 | K211838 | Ultrasonic Bipolar Generator USG-410 with accessories | Olympus Medical Systems Corporation | 2021 | 13 |
| 0 (this device) | K231777 | Electrosurgical Generator ESG-410 and Accessories (WA91327U, WA91327W)… | Olympus Winter & Ibe GmbH | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 2 | 0 |
| 1986 | 1 | 0 |
| 1988 | 2 | 0 |
| 1989 | 1 | 0 |
| 1990 | 2 | 0 |
| 1991 | 7 | 0 |
| 1992 | 4 | 0 |
| 1993 | 3 | 0 |
| 1994 | 9 | 0 |
| 1995 | 14 | 0 |
| 1996 | 13 | 0 |
| 1997 | 8 | 0 |
| 1998 | 10 | 0 |
| 1999 | 7 | 0 |
| 2000 | 14 | 0 |
| 2001 | 7 | 0 |
| 2002 | 6 | 0 |
| 2003 | 9 | 0 |
| 2004 | 4 | 0 |
| 2005 | 6 | 0 |
| 2006 | 6 | 0 |
| 2007 | 6 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 2 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2021 | 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 |
|---|---|---|---|
| * | K203277 | Electrosurgical Generator ESG-410, Foot Switches, PK Cutting ForcepsSummary page 5…evices: Predicate Device Manufacturer 510(k) No. Primary Electrosurgical Generator Olympus Winter & Ibe K203277 Predicate ESG-410 and Accessories GmbH Secondary Olympus ULTRASONIC OLYMPUS MEDICAL K… | 2021 |
| * | K211838 | Ultrasonic Bipolar Generator USG-410 with accessoriesSummary page 5…Olympus Winter & Ibe K203277 Predicate ESG-410 and Accessories GmbH Secondary Olympus ULTRASONIC OLYMPUS MEDICAL K211838 Predicate BIPOLAR GENERATOR SYSTEMS USG-410 Table 2.1: Identification of predicate device 2.… | 2021 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 25, 2025 | Class II | Z-2338-2025 | Component change control | Potential for the ESG-410 Electrosurgical Generator to display an error message: "E0662 System Error", followed by either automatic single reboots of the device, or continuous reboot 'loops'. |
| Sep 4, 2024 | Class II | Z-0264-2025 | Software design | There was an increase in complaints indicating an occurrence of system error E1226 "Could not write to Audio Buffer" during procedures using the ESG-410 (SEP). |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 29 years and passes through 9 companies; a new generation was cleared every 1.2 years on median.
- 22 of the 169 ancestors have a recall of any class.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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 electrosurgical generator, in conjunction with compatible devices and electrosurgical accessories, is intended for
cutting and coagulation of soft tissue and for ligation of vessels. The electrosurgical generator utilizes monopolar and
bipolar high frequency current and supports ultrasonic instruments.
The electrosurgical generator is intended to be used in the following medical fields:
• Open surgery
• Laparoscopic surgery, including single-site surgery
• Endoscopic surgery
Only for use by a qualified physician in an adequate medical environment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K231777 · printed Nov 6, 2026
Cite this page
510(k) Report. “K231777: Electrosurgical Generator ESG-410 and Accessories (WA91327U, WA91327W), Accessories: Foot switches (WA91311W, WA91321W).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K231777
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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