Cleared Traditional

ViVi? Surgical Helmet System (ViVi? Helmet, ViVi? Helmet HPL, ViVi? Hood)

K222214 · Thi Total Healthcare Innovation GmbH · General Hospital
Oct 2023
Decision
449d
Days
Class 2
Risk

About This 510(k) Submission

K222214 is an FDA 510(k) clearance for the ViVi? Surgical Helmet System (ViVi? Helmet, ViVi? Helmet HPL, ViVi? Hood), a Hood, Surgical (Class II — Special Controls, product code FXY), submitted by Thi Total Healthcare Innovation GmbH (Feistritz Im Rosental, AT). The FDA issued a Cleared decision on October 17, 2023, 449 days after receiving the submission on July 25, 2022. This device falls under the General Hospital review panel. Regulated under 21 CFR 878.4040.

Submission Details

510(k) Number K222214 FDA.gov
FDA Decision Cleared SESE
Date Received July 25, 2022
Decision Date October 17, 2023
Days to Decision 449 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code FXY — Hood, Surgical
Device Class Class II — Special Controls
CFR Regulation 21 CFR 878.4040

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