# K040780: Electrosurgical Pencils

- Pathway: 510(k) (Traditional)
- Applicant: Hangzhou Shuyou Medical Instrument Company, Ltd.
- Decided: Feb 10, 2005 after 321 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
Peng's Multifunctional Operative Dissector consists of various types of disposable electrosurgical pencils which are adaptable to common brands of electrosurgical generators for cutting and coagulation to remove tissue and control bleeding by use of high frequency current. Several main models of the electrosurgical pencils can be utilized for suction, and blood, tissue debris, smoke can be removed from the surgical field.

Source page: https://510kreport.com/device/K040780
Methodology: https://510kreport.com/methodology