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510(k) K222214

ViVi® Surgical Helmet System (ViVi® Helmet, ViVi® Helmet HPL, ViVi® Hood) by Thi Total Healthcare Innovation GmbH — Product Code FXY

K222214 is an FDA 510(k) premarket notification submitted by Thi Total Healthcare Innovation GmbH for the device "ViVi® Surgical Helmet System (ViVi® Helmet, ViVi® Helmet HPL, ViVi® Hood)". The FDA issued a decision of Substantially Equivalent on October 17, 2023. The device falls under product code FXY (Hood, Surgical), a Class II device regulated under 21 CFR 878.4040. Thi Total Healthcare Innovation GmbH has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 17, 2023
Date Received
July 25, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Hood, Surgical
Device Class
Class II
Regulation Number
878.4040
Review Panel
HO
Submission Type

Other clearances by Thi Total Healthcare Innovation GmbH

  • K243522 — ViVi® Toga Premium (May 30, 2025)

Other clearances for product code FXY

  • K200493 — Stryker T7 Surgical Hoods, Stryker T7 Surgical Togas, Zippered, Stryker T7 Surgi (March 21, 2020)
  • K140588 — FLYTE HYBRID HOOD, FLYTE HYBRID HOOD WITH PEELAWAY LENS (June 26, 2014)
  • K904969 — HOOD, OPERATING, SURGICAL (December 12, 1990)
  • K904276 — DISPOSABLE BEARD COVER (November 21, 1990)
  • K903533 — STERI-SHIELD (October 19, 1990)
  • K902677 — STERI-SHIELD (August 17, 1990)
  • K880431 — CARETEX SURGEON'S HOODS (February 24, 1988)
  • K770261 — HOOD, CLARION SURGEONS (March 1, 1977)
  • K770257 — HOOD & BEARD COVER, CLARION SURGEON'S (February 25, 1977)
  • K761070 — P.S.M. SURGICAL HOOD (December 30, 1976)

FDA data resources