# K092634: Obs Disposable Electrosurgical Pencils, Models: Obs-DB, Obs-DR, Obs-DF

- Pathway: 510(k) (Traditional)
- Applicant: Jiangmen City Xinhui Baisheng Medical Equipment CO
- Decided: Dec 1, 2009 after 96 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 K001270 (2000). 7 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033027: Shinmed Various Models of Electro-Surgical Pencils, SW12200, SW12202, SW12300, Shining World Health Care Co., Ltd. (2004) Summary page 1.
- K993647: Unimed Disposable Hand and Foot-Switching Pencils with Holster and 1BLADE and Tip Cleaner, Unimed Disposable Hand and F, Unimed Surgical Products, Inc. (1999) Summary page 2.
- K002257: Tecno Disposable Fingerswitch Pencil, Model 150-100, Tecno Instruments (Pvt.), Ltd. (2000) Summary page 2.

## Most influential descendants
- K170369: Disposable Electrosurgical Pencils (2018), 0 descendants of its own

## Indications for use
The 025 Disposable Electrosurgical Pencils, models: OBS-Db, OBS-Dr, OBS-Df are used for cutting and coagulation to remove tissue and control bleeding by using high frequency current during electrosurgical surgery with a 510Ok-clearance ESU generator. The device is disposable and supplied sterile with an electrode tip.

Source page: https://510kreport.com/device/K092634
Methodology: https://510kreport.com/methodology