# K232460: Disposable electrosurgical pencil (MD1000)

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Mecun Medical Supply Co., Ltd.
- Decided: Oct 11, 2023 after 57 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 K965054 (1997). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K213786: CiRX Single use electrosurgical pencil with non-coated and coated electrode, Ningbo Shun YE Medical Company, Ltd. (2022) Summary page 5.

## Indications for use
The device is to be used in combination with a standard electrosurgical generator to cut and coagulate soft tissue by means of high frequency electrical current during an electrosurgical procedure.

Source page: https://510kreport.com/device/K232460
Methodology: https://510kreport.com/methodology