510(k) · Cleared
ClearedArtiSential Laparoscopic Instruments-Electrodes
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Livsmed, Inc. · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Feb 24, 2022 as substantially equivalent to K200875 (Livsmed, Inc., 2020) after a 14-day review. Its family tree reaches back 4 generations to 1991. 1 later device descends from it.
- Decided
- Feb 24, 2022
- Review
- 14 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K904993 (1991). 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK904993 Laparoscopic Electrosurgical DeviceEverest Medical Corp. · 1991
- 3 generations backK031078 Everest Bipolar Macro, Micro & Molly Forceps & Gyrus Bipolar Macro…Gyrus Medical, Inc. · 2003 · Recalled
- 2 generations backK190909 ArtiSential Bipolar Fenestrated ForcepsLivsmed, Inc. · 2020
- 1 generation backK200875 ArtiSential Laparoscopic Instruments - ElectrodesLivsmed, Inc. · 2020
- This deviceK220384 ArtiSential Laparoscopic Instruments-ElectrodesLivsmed, Inc. · 2022
- Descendant · cites it directly · 0 of its ownK230499 ArtiSential Laparoscopic Instruments-ElectrodesLivsmed, Inc. · 2023
Most influential descendants
Showing 1 of 1 · See all- K230499ArtiSential Laparoscopic Instruments-ElectrodesLivsmed, Inc. · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K904993 | Laparoscopic Electrosurgical Device | Everest Medical Corp. | 1991 | — |
| −3 | K031078 | Everest Bipolar Macro, Micro & Molly Forceps & Gyrus Bipolar Macro, Micro &… | Gyrus Medical, Inc. | 2003 | 1 |
| −2 | K190909 | ArtiSential Bipolar Fenestrated Forceps | Livsmed, Inc. | 2020 | — |
| −1 | K200875 | ArtiSential Laparoscopic Instruments - Electrodes | Livsmed, Inc. | 2020 | — |
| 0 (this device) | K220384 | ArtiSential Laparoscopic Instruments-Electrodes | Livsmed, Inc. | 2022 | — |
| +1 | K230499 | ArtiSential Laparoscopic Instruments-Electrodes | Livsmed, Inc. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K200875 | ArtiSential Laparoscopic Instruments - ElectrodesSummary page 4…Applicant Device Name 510(k) Number LivsMed Inc. ArtiSential Laparoscopic Instruments - K200875 Electrodes… | 2020 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K230499 | ArtiSential Laparoscopic Instruments-Electrodes | 2023 | 0 |
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 31 years and passes through 3 companies; a new generation was cleared every 12.3 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K230499 (Livsmed, Inc., 2023) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K200875.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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?
Indications for use include electrosurgical coagulation, dissection, and grasping of tissue during the performance of laparoscopic and general surgical procedures.
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/K220384 · printed Nov 6, 2026
Cite this page
510(k) Report. “K220384: ArtiSential Laparoscopic Instruments-Electrodes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K220384
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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