510(k) · Cleared
ClearedEncision AEM Monopolar Laparoscopic Instruments and Accessories
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Encision Incorporated · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Mar 20, 2020 as substantially equivalent to K912780 (Electroscope, Inc., 1991) and 1 other predicate after a 277-day review. Its family tree reaches back 1 generation to 1991. 1 later device descends from it.
- Decided
- Mar 20, 2020
- Review
- 277 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K912780 (1991). 2 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK912780 Monopolar Laparoscopic Electrodes W/EletroshieldElectroscope, Inc. · 1991 · Recalled
- This deviceK191612 Encision AEM Monopolar Laparoscopic Instruments and AccessoriesEncision Incorporated · 2020
- Descendant · cites it directly · 0 of its ownK201018 Encision AEM enTouch 2X ScissorEncision, Inc. · 2020
Most influential descendants
Showing 1 of 1 · See all- K201018Encision AEM enTouch 2X ScissorEncision, Inc. · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K912780 | Monopolar Laparoscopic Electrodes W/Eletroshield | Electroscope, Inc. | 1991 | 8 |
| 0 (this device) | K191612 | Encision AEM Monopolar Laparoscopic Instruments and Accessories | Encision Incorporated | 2020 | — |
| +1 | K201018 | Encision AEM enTouch 2X Scissor | Encision, Inc. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 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 |
|---|---|---|---|
| * | K912780 | Monopolar Laparoscopic Electrodes W/EletroshieldSummary page 4…Accessories Manufacturer Encision Inc. 510(k) Number K912780 Secondary Predicate Devices: Trade Name ES03XX Series Regulation Name… | 1991 |
| * | K091074 | Aem Disposable Electrodes,Model ESO300 SeriesSummary page 4…Accessories Manufacturer Encision Inc. 510(k) Number K091074 K191612 Page 2/7 Devic… | 2009 |
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 |
|---|---|---|---|
| K201018 | Encision AEM enTouch 2X Scissor | 2020 | 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?
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?
These AEM Instruments incorporate the use of AEM technology and are intended for use in delivering monopolar electrosurgical energy during laparoscopic procedures only. AEM Instruments are intended for use with the AEM Monitoring System and electrosurgical generators having compatibility with the AEM Monitor. Scissors Inserts are intended for use on soft tissue only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K191612 · printed Nov 6, 2026
Cite this page
510(k) Report. “K191612: Encision AEM Monopolar Laparoscopic Instruments and Accessories.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K191612
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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