ILLUMISITE Platform
FDA 510(k) K191394 · Covidien, LLC
510(k) numberK191394
Submission
- Device name
- ILLUMISITE Platform
- Applicant
- Covidien, LLC
Plymouth, MN, US - Received
- May 24, 2019
- Decision date
- August 7, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was ILLUMISITE Platform cleared by the FDA?
ILLUMISITE Platform (K191394) received a 510(k) decision of Substantially Equivalent on August 7, 2019, 75 days after the submission was received.
What is the product code of K191394?
The FDA product code is JAK – System, X-Ray, Tomography, Computed, a Class II (moderate risk) device regulated under 21 CFR 892.1750.