# K101108: Erbe Esu Model Vio 100 C with Accessories

- Pathway: 510(k) (Special)
- Applicant: Erbe USA, Inc.
- Decided: Jul 16, 2010 after 87 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.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080715: Erbe Vio Esu, Model Vio 200 S, Erbe USA, Inc. (2008) Summary page 1.

## Indications for use
The ERBE ESU Model VIO 100 C 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/K101108
Methodology: https://510kreport.com/methodology