ILLUMISITE Platform
K-Number: K191394 · 2019-08-07
ApplicantCovidien, LLC
Decision Date2019-08-07
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
ILLUMISITE Platform is a medical device manufactured by Covidien, LLC. It received FDA 510(k) clearance on 2019-08-07 under approval number K191394. The device is classified under product code JAK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the ILLUMISITE Platform?
ILLUMISITE Platform is a medical device that received FDA 510(k) clearance on 2019-08-07. It is manufactured by Covidien, LLC. The 510(k) number is K191394.
When was ILLUMISITE Platform approved by the FDA?
ILLUMISITE Platform received FDA 510(k) clearance on 2019-08-07, under approval number K191394.
What company makes ILLUMISITE Platform?
ILLUMISITE Platform is manufactured by Covidien, LLC.
What is the FDA product code for ILLUMISITE Platform?
The FDA product code for ILLUMISITE Platform is JAK.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.