# K100258: Electrosurgical Pencil with Electrode, WP200

- Pathway: 510(k) (Abbreviated)
- Applicant: Wickimed Supply Limited
- Decided: Apr 28, 2010 after 90 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The electrosurgical pencil with electrode is a handheld accessory for high voltage high frequency electrosurgical devices. Normally, it operates under a frequency range of 0.2 - 5 MHz with a maximum peak-to-peak voltage level of 9000V. The maximum power of the device is under 400watts. By pressing the Yellow and Blue buttons on the pencil, it performs to CUT tissue and to COAGULATE tissue to stop bleeding during surgical operation. Making use of suitable detachable electrode, it fits various kind of application requirement.

Source page: https://510kreport.com/device/K100258
Methodology: https://510kreport.com/methodology