ViVi® Surgical Helmet System (ViVi® Helmet, ViVi® Helmet HPL, ViVi® Hood)
Summary
Thi Total Healthcare Innovation GmbH received 510(k) clearance for ViVi® Surgical Helmet System (ViVi® Helmet, ViVi® Helmet HPL, ViVi® Hood), a FXY device. Cleared on 2023-10-17.
Details
Source
510(k) Clearance
External ID
K222214
Action Date
2023-10-17
Status
Traditional
Category
device
Product Code
FXY
Product Description
ViVi® Surgical Helmet System (ViVi® Helmet, ViVi® Helmet HPL, ViVi® Hood). Product code: FXY.
Context & Analysis
A 510(k) clearance means the FDA determined this device is substantially equivalent to a legally marketed device. This is one of 403 device clearances issued this month. Thi Total Healthcare Innovation GmbH has received 2 total clearances in our database.
Thi Total Healthcare Innovation GmbH has 2 FDA actions in our database, including 2 clearances.
Frequently Asked Questions
What does 510(k) clearance mean?
A 510(k) is an FDA premarket submission demonstrating that a device is substantially equivalent to a legally marketed device. It does NOT mean FDA approval — it means the device is cleared for marketing because it's similar enough to an existing cleared device. Most medical devices reach market via 510(k) rather than full PMA approval.
How often does Thi Total Healthcare Innovation GmbH have FDA actions?
Thi Total Healthcare Innovation GmbH has 2 FDA actions in our database, including 0 recalls and 2 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K222214" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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