# K210488: Ultrasonic Surgical & Electrosurgical Generator

- Pathway: 510(k) (Traditional)
- Applicant: Surgnova Healthcare Technologies (Zhejiang) Co., Ltd.
- Decided: Oct 25, 2021 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: 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 4.

## Indications for use
The Energy generator intended for use in the operating room for general procedures where ESU cutting and coagulation is required. The Energy generator is equipped with monopolar and bipolar outputs.

Source page: https://510kreport.com/device/K210488
Methodology: https://510kreport.com/methodology