510(k) · Cleared
ClearedNew Deantronics Disposable Laparoscopic Electrodes, non-coated, and coated
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
New Deantronics Taiwan, Ltd. · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Jan 5, 2016 as substantially equivalent to K904560 (Valleylab, Inc., 1990) and 1 other predicate after a 54-day review. Its family tree reaches back 1 generation to 1990. 3 later devices descend from it.
- Decided
- Jan 5, 2016
- Review
- 54 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K904560 (1990). 2 ancestors in all. 3 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK904560 Valleylab Laparoscopic Handswitch/ElectrodesValleylab, Inc. · 1990
- This deviceK153265 New Deantronics Disposable Laparoscopic Electrodes, non-coated, and…New Deantronics Taiwan, Ltd. · 2016
- Descendant · cites it directly · 1 of its ownK231298 Ultravision2™ System Integrated Monopolar L-Hook (H/S)™Alesi Surgical, Ltd. · 2023
- Descendant · 2 generations on · 0 of its ownK240868 Ultravision2™ IonPencilAlesi Surgical Limited · 2024
- Descendant · cites it directly · 0 of its ownK183594 Laparoscopic Curved Spatula Electrode, Retractable, Aspiration Hole…New Deantronics Taiwan, Ltd. · 2019
Most influential descendants
Showing 3 of 3 · See all- K231298Ultravision2™ System Integrated Monopolar L-Hook (H/S)™Alesi Surgical, Ltd. · 2023 · cites it directly1descendant
- K240868Ultravision2™ IonPencilAlesi Surgical Limited · 2024 · 2 generations on0descendants
- K183594Laparoscopic Curved Spatula Electrode, Retractable, Aspiration Hole, 28cm ; Laparoscopic…New Deantronics Taiwan, Ltd. · 2019 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K904560 | Valleylab Laparoscopic Handswitch/Electrodes | Valleylab, Inc. | 1990 | — |
| 0 (this device) | K153265 | New Deantronics Disposable Laparoscopic Electrodes, non-coated, and coated | New Deantronics Taiwan, Ltd. | 2016 | — |
| +1 | K231298 | Ultravision2™ System Integrated Monopolar L-Hook (H/S)™ | Alesi Surgical, Ltd. | 2023 | — |
| +2 | K240868 | Ultravision2™ IonPencil | Alesi Surgical Limited | 2024 | — |
| +1 | K183594 | Laparoscopic Curved Spatula Electrode, Retractable, Aspiration Hole, 28cm… | New Deantronics Taiwan, Ltd. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2023 | 1 | 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? (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 |
|---|---|---|---|
| * | K904560 | Valleylab Laparoscopic Handswitch/ElectrodesSummary page 4…surgical procedures where monopolar electrosurgical cutting and coagulation are desired. VI. Predicate Device Non-coated laparoscopic electrode Valleylab, Inc. 510(k) K904560 Cleared for marketing on December 31, 1990. Coated laparoscopic electrode Megadyne Medical Products, Inc. E-Z Clean Laparoscopi… | 1990 |
| * | K913281 | E-Z Clean Laparoscopic ElectrodeSummary page 4…, Inc. 510(k) K904560 Cleared for marketing on December 31, 1990. Coated laparoscopic electrode Megadyne Medical Products, Inc. E-Z Clean Laparoscopic Electrode 510(k) K913281 Cleared for marketing on Aug. 16, 1991. VII. Device Description and Technological Characteristics The disposable laparoscopic e… | 1991 |
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?
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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 disposable laparoscopic electrodes are intended for use in minimally invasive surgical procedures where monopolar electrosurgical cutting and coagulation are desired.
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/K153265 · printed Nov 6, 2026
Cite this page
510(k) Report. “K153265: New Deantronics Disposable Laparoscopic Electrodes, non-coated, and coated.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K153265
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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