510(k) · Cleared
ClearedArtiSential Laparoscopic Instrument-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 May 11, 2020 as substantially equivalent to K091869 (Covidien Lp, Formerly Registered AS United States, 2009) after a 73-day review. Its family tree reaches back 2 generations to 1990. 4 later devices descend from it.
- Decided
- May 11, 2020
- Review
- 73 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K904578 (1990). 6 ancestors in all. 4 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK904578 Modification Auto Suture (R) Endoscopic ClampUnited States Surgical, A Division of Tyco Healthc · 1990
- 1 generation backK091869 Sils Clincher, Sils Dissector, Sils Grasper, Sils L-Hook, Sils ShearsCovidien Lp, Formerly Registered AS United States · 2009
- This deviceK200501 ArtiSential Laparoscopic Instrument-ElectrodesLivsmed, Inc. · 2020
- Descendant · cites it directly · 1 of its ownK230498 ArtiSential Laparoscopic Instruments-ElectrodesLivsmed, Inc. · 2023
- Descendant · cites it directly · 1 of its ownK203580 ArtiSential Laparoscopic Instruments-ElectrodesLivsmed, Inc. · 2021
- Descendant · 2 generations on · 0 of its ownK240657 ArtiSential Laparoscopic Instruments-Electrodes (AMHD01-LH)…Livsmed, Inc. · 2024
- Descendant · 2 generations on · 0 of its ownK230539 ArtiSential Laparoscopic Instruments-ElectrodesLivsmed, Inc. · 2023
Most influential descendants
Showing 4 of 4 · See all- K230498ArtiSential Laparoscopic Instruments-ElectrodesLivsmed, Inc. · 2023 · cites it directly1descendant
- K203580ArtiSential Laparoscopic Instruments-ElectrodesLivsmed, Inc. · 2021 · cites it directly1descendant
- K240657ArtiSential Laparoscopic Instruments-Electrodes (AMHD01-LH); ArtiSential Laparoscopic…Livsmed, Inc. · 2024 · 2 generations on0descendants
- K230539ArtiSential Laparoscopic Instruments-ElectrodesLivsmed, Inc. · 2023 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K904578 | Modification Auto Suture (R) Endoscopic Clamp | United States Surgical, A Division of Tyco Healthc | 1990 | — |
| −1 | K091869 | Sils Clincher, Sils Dissector, Sils Grasper, Sils L-Hook, Sils Shears | Covidien Lp, Formerly Registered AS United States | 2009 | — |
| 0 (this device) | K200501 | ArtiSential Laparoscopic Instrument-Electrodes | Livsmed, Inc. | 2020 | — |
| +1 | K230498 | ArtiSential Laparoscopic Instruments-Electrodes | Livsmed, Inc. | 2023 | — |
| +1 | K203580 | ArtiSential Laparoscopic Instruments-Electrodes | Livsmed, Inc. | 2021 | — |
| +2 | K240657 | ArtiSential Laparoscopic Instruments-Electrodes (AMHD01-LH); ArtiSential… | Livsmed, Inc. | 2024 | — |
| +2 | K230539 | ArtiSential Laparoscopic Instruments-Electrodes | Livsmed, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1992 | 2 | 0 |
| 1995 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 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 |
|---|---|---|---|
| * | K091869 | Sils Clincher, Sils Dissector, Sils Grasper, Sils L-Hook, Sils ShearsSummary page 4…vice Applicant Device Name 510(k) Number Covidien LP TM K091869 SILS L-Hook K200501… | 2009 |
| † | K190909 | ArtiSential Bipolar Fenestrated Forceps | 2020 |
| † | K142868 | 5mm Laparoscopic Electrode with J Hook, 5mm Laparoscopic Electrode with L Hook, 5mm… | 2014 |
What descends from it? (4)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 30 years and passes through 3 companies; a new generation was cleared every 18.8 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K230498 (Livsmed, Inc., 2023) has gone furthest, with 1 descendant of its own.
- 4 other devices also cite its predicate K091869.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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?
ArtiSential Laparoscopic Instruments-Electrodes, Monopolar Series are indicated for cutting and coagulation in endoscopic, gynecological, and general abdominal and thoracic and general laparoscopic procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K200501 · printed Nov 3, 2026
Cite this page
510(k) Report. “K200501: ArtiSential Laparoscopic Instrument-Electrodes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K200501
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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