# K083452: Erbe Model Vio 300 D with Accessories

- Pathway: 510(k) (Special)
- Applicant: Erbe USA, Inc.
- Decided: Dec 31, 2008 after 40 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: 3 generations back to K933002 (1994). 3 ancestors in all.
55 later devices descend from it; 10 cite it directly.
0 of 59 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023886: Erbe Vio Esu with Accessories, Model Vio 300 D, Erbe USA, Inc. (2002) Summary page 1.
- K060484: Erbe Vio Esu, Model Vio 300 D, Erbe USA, Inc. (2006) Summary page 1.

## Most influential descendants
- K134054: Bovie Ids-310 High Frequency Electrosurgical Generator, Aaron A3350 High Frequency Electrosurgical Generator (2014), 39 descendants of its own
- K161134: Bovie Bantam/PRO Electrosurgical Generator, Bovie DERM 941 Electrosurgical Generator, Bovie DERM 942 Electrosurgical Generator (2016), 14 descendants of its own
- K192813: Plasma IQ (2020), 12 descendants of its own
- K142975: Bovie Ultimate High Frequency Electrosurgical Generator (2014), 12 descendants of its own
- K170188: Bovie J-Plasma Precise Open handpiece & Bovie Ultimate Gen 2 High Frequency Electrosurgical Generator (2017), 11 descendants of its own

## Indications for use
The ERBE ESU Model VIO 300 D 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/K083452
Methodology: https://510kreport.com/methodology
