# K251108: Erbe ESU Model VIO® 3n with Accessories

- Pathway: 510(k) (Traditional)
- Applicant: Erbe Elektromedizin GmbH
- Decided: Aug 29, 2025 after 140 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: 7 generations back to K870028 (1987). 36 ancestors in all.
No later device cites it as a predicate yet.
1 of 37 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K240932: HybridTherm System, Erbe Elektromedizin GmbH (2024) Summary page 5.
- K083452: Erbe Model Vio 300 D with Accessories, Erbe USA, Inc. (2008) Summary page 5.

## Indications for use
The Erbe Electrosurgical Unit (ESU/Generator) model VIO 3n with instruments and accessories is intended to deliver high frequency (HF) electrical current for the cutting and/or coagulation of tissue.

Source page: https://510kreport.com/device/K251108
Methodology: https://510kreport.com/methodology