510(k) · Cleared
ClearedMultifunctional Operational Dissectors (Electrosurgical Pencils);Multifunctional Operational Dissectors (Disposable Electrode)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zhejiang shuyou Surgical Instrument Co., Ltd. · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Apr 7, 2026 as substantially equivalent to K230547 (Conmed Corporation, 2023) after a 54-day review. Its family tree reaches back 3 generations to 1994.
- Decided
- Apr 7, 2026
- Review
- 54 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K936304 (1994). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK936304 Electrosurgical PencilE & M Engineering, Inc. · 1994 · Recalled
- 2 generations backK103375 Plumepen Integrated Smoke Evacuation PencilMedtek Devices, Inc. · 2011
- 1 generation backK230547 PlumePen Elite Surgical Smoke Evacuation Pencils, PlumePen Pro…Conmed Corporation · 2023
- This deviceK260466 Multifunctional Operational Dissectors (Electrosurgical…Zhejiang shuyou Surgical Instrument Co., Ltd. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K936304 | Electrosurgical Pencil | E & M Engineering, Inc. | 1994 | 3 |
| −2 | K103375 | Plumepen Integrated Smoke Evacuation Pencil | Medtek Devices, Inc. | 2011 | — |
| −1 | K230547 | PlumePen Elite Surgical Smoke Evacuation Pencils, PlumePen Pro Surgical Smoke… | Conmed Corporation | 2023 | — |
| 0 (this device) | K260466 | Multifunctional Operational Dissectors (Electrosurgical… | Zhejiang shuyou Surgical Instrument Co., Ltd. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 2000 | 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 |
|---|---|---|---|
| * | K230547 | PlumePen Elite Surgical Smoke Evacuation Pencils, PlumePen Pro Surgical Smoke Evacuation…Summary page 6…of the six types of disposable electrode is different. 4. Identification of Predicate Devices and Reference Device Predicate Device 510K Number: K230547 Trade Name: PlumePen (Elite, Pro and Ultra) Surgical Smoke Evacuation Pencil Reference Device 510K Number: K1… | 2023 |
| † | K192542 | Foot Control Electrosurgical Pencil, Push Button Electrosurgical Pencil, Rocker Switch… | 2020 |
What descends from it?
No later submission names this one as a predicate yet.
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 32 years and passes through 4 companies; a new generation was cleared every 12.1 years on median.
- 1 of the 5 ancestors has a recall of any class.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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?
Electrosurgical Pencil and Accessories designed for general electrosurgical applications, including cutting and coagulation, illumination and for removing smoke generated by electrosurgery when used in conjunction with an effective smoke evacuation system. The electrosurgical pencil enables the operator to remotely conduct an electrosurgical current from the output connector of an electrosurgical unit to the operative site for the desired surgical…
Read the full statement (101 words)
Electrosurgical Pencil and Accessories designed for general electrosurgical applications, including cutting and coagulation, illumination and for removing smoke generated by electrosurgery when used in conjunction with an effective smoke evacuation system. The electrosurgical pencil enables the operator to remotely conduct an electrosurgical current from the output connector of an electrosurgical unit to the operative site for the desired surgical effect.
Electrosurgical Electrode Accessories designed for general electrosurgical applications, including cutting and coagulation. The electrosurgical electrode enables the operator to remotely conduct an electrosurgical current from the output connector of an electrosurgical unit to the operative site for the desired surgical effect.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K260466 · printed Nov 3, 2026
Cite this page
510(k) Report. “K260466: Multifunctional Operational Dissectors (Electrosurgical Pencils);Multifunctional Operational Dissectors (Disposable Electrode).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K260466
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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