# K243522: ViVi® Toga Premium

- Pathway: 510(k) (Traditional)
- Applicant: Thi Total Healthcare Innovation GmbH
- Decided: May 30, 2025 after 197 days
- Product code: FYA (Gown, Surgical)
- Device class: 2
- Regulation: 21 CFR 878.4040
- 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 K192194 (2019). 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)
- K192194: TotalShield II Surgical Helmet System, Zimmer Surgical, Inc. (2019) Summary page 5.

## Indications for use
The ViVi® Toga Premium is a component of the ViVi® System and is intended to be worn by surgical personnel to provide a barrier between the operating environment and the surgical personnel in order to help protect against contamination and/or exposure of infectious body fluids and harmful microorganisms.

Source page: https://510kreport.com/device/K243522
Methodology: https://510kreport.com/methodology