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FXY

Hood, Surgical

Product code
FXY
Device name
Hood, Surgical
Device class
Class 2
21 CFR
21 CFR 878.4040
Medical specialty
General, Plastic Surgery
Marketing pathway
510(K)
Flag
Third-party review eligible
510(k) clearances (last 3 years)
1
Summaries archived here
1 (direct download)
510(k) clearances (all years, FDA)
13 (all years; only the last 3 years are listed here)

510(k) clearances, last 3 years (1)

Last three years. Most recent: 2023-10-17.

NumberDecision dateApplicantDevice nameSummary
K2222142023-10-17Thi Total Healthcare Innovation GmbHViVi® Surgical Helmet System (ViVi® Helmet, ViVi® He…PDF

1 summaries are archived here for direct download.

Official FDA classification page: FXY
Classification and pathway per current FDA publications. Data from openFDA (CC0).