ArthrexVIP Web Portal
FDA 510(k) K193523 · Arthrex, Inc.
510(k) numberK193523
Submission
- Device name
- ArthrexVIP Web Portal
- Applicant
- Arthrex, Inc.
Naples, FL, US - Received
- December 19, 2019
- Decision date
- April 30, 2020
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was ArthrexVIP Web Portal cleared by the FDA?
ArthrexVIP Web Portal (K193523) received a 510(k) decision of Substantially Equivalent on April 30, 2020, 133 days after the submission was received.
What is the product code of K193523?
The FDA product code is LLZ – System, Image Processing, Radiological, a Class II (moderate risk) device regulated under 21 CFR 892.2050.