# K260466: Multifunctional Operational Dissectors (Electrosurgical Pencils);Multifunctional Operational Dissectors (Disposable Electrode)

- Pathway: 510(k) (Traditional)
- Applicant: Zhejiang shuyou Surgical Instrument Co., Ltd.
- Decided: Apr 7, 2026 after 54 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K936304 (1994). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K230547: PlumePen Elite Surgical Smoke Evacuation Pencils, PlumePen Pro Surgical Smoke Evacuation Pencil, PlumePen Ultra Surgical Smoke Evacuation Pencils, PenAdapt Electrosurgical Pencil Adapter, SnapEvac Electrosurgical Pencil Adapter, Conmed Corporation (2023) Summary page 6.

## Indications for use
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.

Source page: https://510kreport.com/device/K260466
Methodology: https://510kreport.com/methodology