510(k) · Cleared
ClearedUniversalplus Laparoscopic Abc/Electrosurgical Electrode
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Conmedcorp · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Jan 2, 1998 after an 80-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 3 later devices descend from it.
- Decided
- Jan 2, 1998
- Review
- 80 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 2 citing it directly.
- This deviceK973890 Universalplus Laparoscopic Abc/Electrosurgical ElectrodeConmedcorp · 1998
- Descendant · cites it directly · 1 of its ownK122580 Aem Disposable Suction Irrigation Handset Model ES1700; Aem…Encision, Inc. · 2012
- Descendant · cites it directly · 1 of its ownK100711 Suction Irrigation Electrodes and AdaptersEncision, Inc. · 2010 · Recalled
- Descendant · 2 generations on · 0 of its ownK131949 Aem Disposable Suction Irrigation ElectrodesEncision, Inc. · 2013
Most influential descendants
Showing 3 of 3 · See all- K122580Aem Disposable Suction Irrigation Handset Model ES1700; Aem Disposable Suction…Encision, Inc. · 2012 · cites it directly1descendant
- K100711Suction Irrigation Electrodes and AdaptersEncision, Inc. · 2010 · cites it directly1descendant
- K131949Aem Disposable Suction Irrigation ElectrodesEncision, Inc. · 2013 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K973890 | Universalplus Laparoscopic Abc/Electrosurgical Electrode | Conmedcorp | 1998 | — |
| +1 | K122580 | Aem Disposable Suction Irrigation Handset Model ES1700; Aem Disposable Suction… | Encision, Inc. | 2012 | — |
| +1 | K100711 | Suction Irrigation Electrodes and Adapters | Encision, Inc. | 2010 | 5 |
| +2 | K131949 | Aem Disposable Suction Irrigation Electrodes | Encision, Inc. | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (3)
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?
- Of its descendants, K122580 (Encision, Inc., 2012) has gone furthest, with 1 descendant 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.
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?
Sterile, single-patient-use electrosurgical accessory having applications in general endoscopy and laparoscopy such as cholecystectomy and are intended to deliver electrosurgical current for cutting and coagulation of tissue and suction/irrigation functions to the surgical site.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K973890 · printed Nov 6, 2026
Cite this page
510(k) Report. “K973890: Universalplus Laparoscopic Abc/Electrosurgical Electrode.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K973890
Report an extraction error
Are you the manufacturer?
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