# K190823: Erbe ESU Model VIO 3 with Accessories

- Pathway: 510(k) (Traditional)
- Applicant: Erbe Elektromedizin GmbH
- Decided: May 22, 2019 after 51 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: 4 generations back to K933002 (1994). 4 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083452: Erbe Model Vio 300 D with Accessories, Erbe USA, Inc. (2008) Summary page 4.

## Most influential descendants
- K240932: HybridTherm System (2024), 1 descendant of its own
- K251108: Erbe ESU Model VIO® 3n with Accessories (2025), 0 descendants of its own

## Indications for use
The Erbe Electrosurgical Unit (ESU/Generator) Model VIO® 3 with Accessories is intended to deliver High Frequency (HF) electrical current for the cutting and/or coagulation of tissue.

Source page: https://510kreport.com/device/K190823
Methodology: https://510kreport.com/methodology