# K170369: Disposable Electrosurgical Pencils

- Pathway: 510(k) (Traditional)
- Applicant: Cathay Manfacturing Corp.
- Decided: Jul 19, 2018 after 528 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: 4 generations back to K001270 (2000). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092634: Obs Disposable Electrosurgical Pencils, Models: Obs-DB, Obs-DR, Obs-DF, Jiangmen City Xinhui Baisheng Medical Equipment CO (2009) Summary page 4.

## Indications for use
The Disposable Electrosurgical Pencil is used for cutting and coagulation to remove tissue and control bleeding by using high frequency during electrosurgical with a specified Electrosurgery Unit (ESU) generator. The device is disposable for single use and supplied as sterile with an electrode tip.

Source page: https://510kreport.com/device/K170369
Methodology: https://510kreport.com/methodology