# K221815: Electrosurgical Pencil (OBS-Db, OBS-Dr, OBS-Dc, OBS-Df, OBS-Di, OBS-De); Electrosurgical Pencil (OBS-Dt, OBS-Dd, OBS-Ds, OBS-Dl, OBS-Da)

- Pathway: 510(k) (Traditional)
- Applicant: Baisheng Medical Co., Ltd.
- Decided: Nov 23, 2022 after 154 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 (OBS-Db, OBS-Dr, OBS-Dc, OBS-Df, OBS-Di, OBS-De) is used for cutting and coagulation to remove tissue and control bleeding by using high frequency current during electrosurgical surgery with an electrosurgical generator. The device is disposable and supplied sterile with an electrode tip. The Electrosurgical Pencil (OBS-Dt, OBS-Dd, OBS-Ds, OBS-Dl, OBS-Da) is used for cutting and coagulation to remove tissue and control bleeding by using high frequency current during electrosurgical surgery with an electrosurgical generator, and for removing smoke generated by electrosurgery when used in conjunction with an effective smoke evacuation system.

Source page: https://510kreport.com/device/K221815
Methodology: https://510kreport.com/methodology