Cleared Traditional

ViVi? Toga Premium

K243522 · Thi Total Healthcare Innovation GmbH · General Hospital

May 2025

Decision

197d

Days

Class 2

Risk

About This 510(k) Submission

K243522 is an FDA 510(k) clearance for the ViVi? Toga Premium, a Gown, Surgical (Class II — Special Controls, product code FYA), submitted by Thi Total Healthcare Innovation GmbH (Feistritz Im Rosental, AT). The FDA issued a Cleared decision on May 30, 2025, 197 days after receiving the submission on November 14, 2024. This device falls under the General Hospital review panel. Regulated under 21 CFR 878.4040.

Submission Details

510(k) Number	K243522 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 14, 2024
Decision Date	May 30, 2025
Days to Decision	197 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF