# K231405: Sterile Single Use Electrosurgical Pencil with Non-Coated Electrode, Sterile Single Use Electrosurgical Pencil with Non-Stick Electrode

- Pathway: 510(k) (Traditional)
- Applicant: Jiangsu Rong FU Kang Medical Instruments Co., Ltd.
- Decided: Jan 18, 2024 after 248 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: 2 generations back to K965054 (1997). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192542: Foot Control Electrosurgical Pencil, Push Button Electrosurgical Pencil, Rocker Switch Electrosurgical Pencil, Holster, Electorde, Modern Medical Equipment Manufacturing, Ltd. (2020) Summary page 4.

## Indications for use
The devices are used to cut and coagulate soft tissue by means of high frequency electrical current during an electrosurgical procedure.

Source page: https://510kreport.com/device/K231405
Methodology: https://510kreport.com/methodology