510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K222214Substantially Equivalent

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

Thi Total Healthcare Innovation GmbH, Feistritz Im Rosental, AT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K222214 is the FDA 510(k) clearance record for ViVi® Surgical Helmet System (ViVi® Helmet, ViVi® Helmet HPL, ViVi® Hood), a class II device, cleared for Thi Total Healthcare Innovation GmbH on under FDA product code FXY (Hood, Surgical). FDA records list 2 510(k) clearances for Thi Total Healthcare Innovation GmbH, from to . As of , FDA records show no recalls naming K222214.

Clearance record

Decision date
Received
(449 days to decision)
Product code
FXY Hood, Surgical
Regulation
21 CFR 878.4040
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Thi Total Healthcare Innovation GmbH Gewerbestrasse 4, Feistritz Im Rosental, AT
510(k) summary
Summary PDF
Third party review
No

Clearances, product code FXY

Trailing 12 months

FDA records hold no clearances under product code FXY in the trailing twelve months.

FDA records show no clearances under product code FXY in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code FXY, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260