# K162034: OBS Electrosurgical Generator (Model: OBS-350A)

- Pathway: 510(k) (Traditional)
- Applicant: Baisheng Medical Co., Ltd.
- Decided: Jan 30, 2017 after 192 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: 1 generation back to K944602 (1995). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K944602: Valleylab Force FX, Valleylab, Inc. (1995) Summary page 5.

## Indications for use
The Electrosurgical Generator (OBS-350A) is a non-sterile, reusable multi-purpose electrosurgical generator that is designed to perform monopolar and bipolar functions in the surgical operation area.

Source page: https://510kreport.com/device/K162034
Methodology: https://510kreport.com/methodology