510(k) · Cleared
ClearedDisposable Aem Fixed Tip Electrodes and Handpieces
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Encision, Inc. · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Oct 19, 2007 after an 18-day review. The FDA summary names its predicate without a number. 3 later devices descend from it.
- Decided
- Oct 19, 2007
- Review
- 18 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 1 citing it directly.
- This deviceK072789 Disposable Aem Fixed Tip Electrodes and HandpiecesEncision, Inc. · 2007
- Descendant · cites it directly · 2 of its ownK093622 Aem Monitoring System, Models EM2, Emr, ES4007, ES4107, ES9005 and…Encision, Inc. · 2010
- Descendant · 2 generations on · 1 of its ownK122383 EM3 Aem Monitor Aem ConnectorsEncision, Inc. · 2013
- Descendant · 3 generations on · 0 of its ownK140006 Endoshield Burn Protection SystemEncision, Inc. · 2014
Most influential descendants
Showing 3 of 3 · See all- K093622Aem Monitoring System, Models EM2, Emr, ES4007, ES4107, ES9005 and ES9015Encision, Inc. · 2010 · cites it directly2descendants
- K122383EM3 Aem Monitor Aem ConnectorsEncision, Inc. · 2013 · 2 generations on1descendant
- K140006Endoshield Burn Protection SystemEncision, Inc. · 2014 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K072789 | Disposable Aem Fixed Tip Electrodes and Handpieces | Encision, Inc. | 2007 | — |
| +1 | K093622 | Aem Monitoring System, Models EM2, Emr, ES4007, ES4107, ES9005 and ES9015 | Encision, Inc. | 2010 | — |
| +2 | K122383 | EM3 Aem Monitor Aem Connectors | Encision, Inc. | 2013 | — |
| +3 | K140006 | Endoshield Burn Protection System | Encision, Inc. | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 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? (6)
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 |
|---|---|---|---|
| * | — | Model ES1000 series Monopolar Laparoscopic Electrodes with Electroshield Named without a submission number | |
| * | — | Model 30-6000 series Reusable Monopolar Electrodes Named without a submission number | |
| * | — | Model 8380 series Bipolar Electrodes Named without a submission number | |
| * | — | Models SW11100, SW112100, SW11202, SW11300 (Reusable) and SW11220, SW12202, SW12300… Named without a submission number | |
| * | — | Model ES4000 AEM Cord (A-EM Monitor accessory) Named without a submission number | |
| * | — | Model E2508 Disposable Pencil Named without a submission number |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K093622 | Aem Monitoring System, Models EM2, Emr, ES4007, ES4107, ES9005 and ES9015 | 2010 | 2 |
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?
- Of its descendants, K093622 (Encision, Inc., 2010) has gone furthest, with 2 descendants of its own.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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?
The AEM Disposable Electrodes and AEM Disposable Handpieces are electrosurgical accessories intended, by use of monopolar high-frequency electrical current from compatible electrosurgical generators, for ablation, removal, resection and coagulation of soft tissue where associated hemostasis is required in open, endoscopic and laparoscopic surgical procedures.
The devices are intended for use by qualified medical personnel trained in the use of electrosurgical equipment,
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K072789 · printed Nov 4, 2026
Cite this page
510(k) Report. “K072789: Disposable Aem Fixed Tip Electrodes and Handpieces.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K072789
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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