Exciplex
K-Number: K191086 · 2019-12-11
ApplicantClarteis
Decision Date2019-12-11
Product CodeFTC
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Exciplex is a medical device manufactured by Clarteis. It received FDA 510(k) clearance on 2019-12-11 under approval number K191086. The device is classified under product code FTC. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Exciplex?
Exciplex is a medical device that received FDA 510(k) clearance on 2019-12-11. It is manufactured by Clarteis. The 510(k) number is K191086.
When was Exciplex approved by the FDA?
Exciplex received FDA 510(k) clearance on 2019-12-11, under approval number K191086.
What company makes Exciplex?
Exciplex is manufactured by Clarteis.
What is the FDA product code for Exciplex?
The FDA product code for Exciplex is FTC.
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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.