510(k) · Cleared
Recalled · Class II · 2014Everest Bipolar Macro, Micro & Molly Forceps & Gyrus Bipolar Macro, Micro & Molly 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 May 16, 2003 as substantially equivalent to K904993 (Everest Medical Corp., 1991) after a 42-day review. Its family tree reaches back 1 generation to 1991. 5 later devices descend from it. It has been recalled once.
- Decided
- May 16, 2003
- Review
- 42 days
- Class
- Class II
- Product code
- GEI
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K904993 (1991). 5 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK904993 Laparoscopic Electrosurgical DeviceEverest Medical Corp. · 1991
- This deviceK031078 Everest Bipolar Macro, Micro & Molly Forceps & Gyrus Bipolar Macro…Gyrus Medical, Inc. · 2003
- Descendant · cites it directly · 4 of its ownK190909 ArtiSential Bipolar Fenestrated ForcepsLivsmed, Inc. · 2020
- Descendant · 2 generations on · 3 of its ownK200875 ArtiSential Laparoscopic Instruments - ElectrodesLivsmed, Inc. · 2020
- Descendant · 3 generations on · 1 of its ownK220384 ArtiSential Laparoscopic Instruments-ElectrodesLivsmed, Inc. · 2022
- Descendant · 3 generations on · 0 of its ownK252666 Articulator Arthroscopic BurJoint Preservation Innovations, LLC · 2025
- Descendant · 3 generations on · 0 of its ownK230499 ArtiSential Laparoscopic Instruments-ElectrodesLivsmed, Inc. · 2023
Most influential descendants
Showing 5 of 5 · See all- K190909ArtiSential Bipolar Fenestrated ForcepsLivsmed, Inc. · 2020 · cites it directly4descendants
- K200875ArtiSential Laparoscopic Instruments - ElectrodesLivsmed, Inc. · 2020 · 2 generations on3descendants
- K220384ArtiSential Laparoscopic Instruments-ElectrodesLivsmed, Inc. · 2022 · 3 generations on1descendant
- K252666Articulator Arthroscopic BurJoint Preservation Innovations, LLC · 2025 · 3 generations on0descendants
- K230499ArtiSential Laparoscopic Instruments-ElectrodesLivsmed, Inc. · 2023 · 3 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) | K031078 | Everest Bipolar Macro, Micro & Molly Forceps & Gyrus Bipolar Macro, Micro &… | Gyrus Medical, Inc. | 2003 | — |
| +1 | K190909 | ArtiSential Bipolar Fenestrated Forceps | Livsmed, Inc. | 2020 | — |
| +2 | K200875 | ArtiSential Laparoscopic Instruments - Electrodes | Livsmed, Inc. | 2020 | — |
| +3 | K220384 | ArtiSential Laparoscopic Instruments-Electrodes | Livsmed, Inc. | 2022 | — |
| +3 | K252666 | Articulator Arthroscopic Bur | Joint Preservation Innovations, LLC | 2025 | — |
| +3 | K230499 | ArtiSential Laparoscopic Instruments-Electrodes | Livsmed, Inc. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 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…1 medical device. The Everest Bipolar MACRO, MICRO & MOLLY Forceps and Gyrus Bipolar MACRO, MICRO & MOLLY Forceps is a modification to the predicate device cleared under K904993. The Everest Bipolar MACRO, MICRO & MOLLY Forceps and Gyrus Bipolar MACRO, MICRO & MOLLY Forceps is identical in construction (wi… | 1991 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K190909 | ArtiSential Bipolar Fenestrated Forceps | 2020 | 4 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 27, 2014 | Class II | Z-0100-2015 | Packaging process control | Due to an anomaly in the packaging process, it is possible that a defective seal could be present that may allow a breach of the package's sterile barrier and may compromise the sterility of the product. |
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, 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/K031078 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031078: Everest Bipolar Macro, Micro & Molly Forceps & Gyrus Bipolar Macro, Micro & Molly Forceps.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031078
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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