K243522
- 510(k) number
- K243522
- Device name
- ViVi® Toga Premium
- Applicant
- Thi Total Healthcare Innovation GmbH AT
- Product code
- FYA — Gown, Surgical
- Decision date
- 2025-05-30
- Date received
- 2024-11-14
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 1.3 MB · U.S. public domain
Also available from FDA: K243522.pdf
Official FDA record: K243522
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.