510(k) · Cleared
Recalled · Class II · 2026Everest Bipolar Cutting Forceps and Gyrus Bipolar Cutting Forceps
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Gyrus Medical, Inc. · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Nov 13, 2002 as substantially equivalent to K904993 (Everest Medical Corp., 1991) after a 26-day review. Its family tree reaches back 1 generation to 1991. 4 later devices descend from it. It has been recalled 8 times.
- Decided
- Nov 13, 2002
- Review
- 26 days
- Class
- Class II
- Product code
- GEI
- Recalls
- 8
- Predicates
- 1
Its longest line of descent runs back 1 generation to K904993 (1991). 4 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK904993 Laparoscopic Electrosurgical DeviceEverest Medical Corp. · 1991
- This deviceK023492 Everest Bipolar Cutting Forceps and Gyrus Bipolar Cutting ForcepsGyrus Medical, Inc. · 2002
- Descendant · cites it directly · 3 of its ownK100896 Gyrus Acmi Halo PKS Cutting ForcepsGyrus Acmi, Inc. · 2010 · Recalled
- Descendant · 2 generations on · 2 of its ownK142759 PK Cutting Forceps for ESG-400 WorkstationGyrus Acmi, Inc. · 2015
- Descendant · 3 generations on · 1 of its ownK203277 Electrosurgical Generator ESG-410, Foot Switches, PK Cutting ForcepsOlympus Winter & Ibe GmbH · 2021 · Recalled
- Descendant · 4 generations on · 0 of its ownK231777 Electrosurgical Generator ESG-410 and Accessories (WA91327U…Olympus Winter & Ibe GmbH · 2023 · Recalled
Most influential descendants
Showing 4 of 4 · See all- K100896Gyrus Acmi Halo PKS Cutting ForcepsGyrus Acmi, Inc. · 2010 · cites it directly3descendants
- K142759PK Cutting Forceps for ESG-400 WorkstationGyrus Acmi, Inc. · 2015 · 2 generations on2descendants
- K203277Electrosurgical Generator ESG-410, Foot Switches, PK Cutting ForcepsOlympus Winter & Ibe GmbH · 2021 · 3 generations on1descendant
- K231777Electrosurgical Generator ESG-410 and Accessories (WA91327U, WA91327W), Accessories…Olympus Winter & Ibe GmbH · 2023 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K904993 | Laparoscopic Electrosurgical Device | Everest Medical Corp. | 1991 | — |
| 0 (this device) | K023492 | Everest Bipolar Cutting Forceps and Gyrus Bipolar Cutting Forceps | Gyrus Medical, Inc. | 2002 | — |
| +1 | K100896 | Gyrus Acmi Halo PKS Cutting Forceps | Gyrus Acmi, Inc. | 2010 | 1 |
| +2 | K142759 | PK Cutting Forceps for ESG-400 Workstation | Gyrus Acmi, Inc. | 2015 | — |
| +3 | K203277 | Electrosurgical Generator ESG-410, Foot Switches, PK Cutting Forceps | Olympus Winter & Ibe GmbH | 2021 | 4 |
| +4 | K231777 | Electrosurgical Generator ESG-410 and Accessories (WA91327U, WA91327W)… | Olympus Winter & Ibe GmbH | 2023 | 2 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2015 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 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 |
|---|---|---|---|
| * | K904993 | Laparoscopic Electrosurgical DeviceSummary page 1…Forceps and Gyrus Bipolar Cutting Forceps This device is a Class I1 medical device. The Bipolar Cutting Forceps is a modification to the predicate devices cleared under K904993. The Bipolar Cutting Forceps is similar in construction (with the exception of shaft length) and in component materials when comp… | 1991 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K100896 | Gyrus Acmi Halo PKS Cutting Forceps | 2010 | 3 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 25, 2026 | Class II | Z-1643-2026 | Nonconforming Material/Component | Olympus identified that the Cutting Forceps contain components for which the supplier did not adequately validate the welding process. Defective welds can result in the Cutting Forceps' jaw breaking during clinical use. |
| Feb 25, 2026 | Class II | Z-1639-2026 | Nonconforming Material/Component | Olympus identified that the Cutting Forceps contain components for which the supplier did not adequately validate the welding process. Defective welds can result in the Cutting Forceps' jaw breaking during clinical use. |
| Feb 25, 2026 | Class II | Z-1638-2026 | Nonconforming Material/Component | Olympus identified that the Cutting Forceps contain components for which the supplier did not adequately validate the welding process. Defective welds can result in the Cutting Forceps' jaw breaking during clinical use. |
| Feb 25, 2026 | Class II | Z-1642-2026 | Nonconforming Material/Component | Olympus identified that the Cutting Forceps contain components for which the supplier did not adequately validate the welding process. Defective welds can result in the Cutting Forceps' jaw breaking during clinical use. |
| Feb 25, 2026 | Class II | Z-1644-2026 | Nonconforming Material/Component | Olympus identified that the Cutting Forceps contain components for which the supplier did not adequately validate the welding process. Defective welds can result in the Cutting Forceps' jaw breaking during clinical use. |
| Jul 1, 2024 | Class II | Z-2542-2024 | Package design/selection | Fractures and breakages in packaging trays and Tyvek covers, which may result in a sterility breach |
| Jul 1, 2024 | Class II | Z-2540-2024 | Package design/selection | Fractures and breakages in packaging trays and Tyvek covers, which may result in a sterility breach |
| Jul 1, 2024 | Class II | Z-2541-2024 | Package design/selection | Fractures and breakages in packaging trays and Tyvek covers, which may result in a sterility breach |
The 5 latest of 8 recalls; the web page lists all.
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?
Electrosurgical coagulation, mechanical cutting, dissection, and grasping of tissue during
the performance of laparoscopic and general surgical procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K023492 · printed Nov 4, 2026
Cite this page
510(k) Report. “K023492: Everest Bipolar Cutting Forceps and Gyrus Bipolar Cutting Forceps.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K023492
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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