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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Covidien, LLC. It received FDA 510(k) clearance on 2019-08-07 under 510(k) 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. The listed applicant is Covidien, LLC. The 510(k) number is K191394.

When did ILLUMISITE Platform receive FDA 510(k) clearance?

ILLUMISITE Platform received FDA 510(k) clearance on 2019-08-07, under 510(k) number K191394.

Who is the listed applicant for ILLUMISITE Platform?

The FDA 510(k) record lists Covidien, LLC as the applicant. This does not by itself establish the device manufacturer.

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.

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