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ViVi® Surgical Helmet System (ViVi® Helmet +2 more)

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K222214

by Thi Total Healthcare Innovation Gmbh

Identifiers

510(k) Number
K222214 FDA 510(k)
FDA Product Code
FXY FDA 510(k)
Models / Variants
ViVi® Helmet FDA 510(k)EUDAMED
ViVi® Helmet HPL FDA 510(k)EUDAMED
ViVi® Hood FDA 510(k)EUDAMED

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 878.4040 FDA 510(k)
Regulation Number
878.4040 FDA 510(k)
Advisory Committee
General, Plastic Surgery FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The ViVi Surgical Helmet System is a Surgical Hood, designed to provide sterile barrier protection for surgical personnel during procedures. It includes a helmet and hood configurations, intended to maintain a clean field by reducing contamination from hair, skin, and airborne particles, thereby enhancing surgical site integrity.

The system is supplied as a single-use, non-sterile device and must be sterilized prior to use, typically via ethylene oxide or gamma irradiation. It is classified as a Class II medical device under FDA regulations and is authorized for use in general and plastic surgery settings. Multiple sizes and variants are available, as indicated by the registration numbers, and compliance with FDA 510(k) and MDR requirements ensures its regulatory standing.

Frequently asked questions

What types of surgical procedures is the ViVi® Surgical Helmet System intended to support, and how does it contribute to surgical site integrity?

The ViVi® Surgical Helmet System is designed for use in general and plastic surgery settings. It provides sterile barrier protection for surgical personnel by reducing contamination from hair, skin, and airborne particles, which helps maintain a cleaner surgical field and enhances the integrity of the surgical site.

Is the ViVi® Surgical Helmet System single-use or reusable, and what sterilization methods are recommended?

The ViVi® Surgical Helmet System is supplied as a single-use, non-sterile device and must be sterilized prior to use. Recommended sterilization methods include ethylene oxide or gamma irradiation to ensure proper sterilization before clinical application.

Are there multiple sizes or variants available for the ViVi® Surgical Helmet System, and how can I identify them?

Yes, the ViVi® Surgical Helmet System includes multiple sizes and variants, as indicated by the registration numbers (e.g., 3013557562, 3014213264, etc.). These variants are designed to accommodate different user preferences and procedural needs, ensuring a proper fit and effective barrier protection.

How is the regulatory status of the ViVi® Surgical Helmet System confirmed, and what does this mean for its use?

The ViVi® Surgical Helmet System holds FDA 510(k) clearance and complies with the Medical Device Regulation (MDR). This means it has undergone evaluation to demonstrate substantial equivalence to a predicate device and meets regulatory requirements for safety and effectiveness, ensuring its authorized use in clinical settings.

What is the primary purpose of the ViVi® Helmet HPL variant within the ViVi® Surgical Helmet System?

The ViVi® Helmet HPL variant is part of the ViVi® Surgical Helmet System and is designed to provide sterile barrier protection for surgical personnel, similar to the standard ViVi® Helmet. The inclusion of 'HPL' may indicate a high-performance or specialized variant, but its core function remains focused on reducing contamination from hair, skin, and airborne particles during surgical procedures.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
Thi Total Healthcare Innovation Gmbh

Sources (2)

  • FDA 510(k) K222214 24 fields · synced Oct 6, 2026
  • EUDAMED 1 fields · synced May 18, 2026