Crosperio OTW
K-Number: K160013 · 2016-04-29
ApplicantKANEKA Corporation
Decision Date2016-04-29
Product CodeLIT
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
Crosperio OTW is a medical device manufactured by KANEKA Corporation. It received FDA 510(k) clearance on 2016-04-29 under approval number K160013. The device is classified under product code LIT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Crosperio OTW?
Crosperio OTW is a medical device that received FDA 510(k) clearance on 2016-04-29. It is manufactured by KANEKA Corporation. The 510(k) number is K160013.
When was Crosperio OTW approved by the FDA?
Crosperio OTW received FDA 510(k) clearance on 2016-04-29, under approval number K160013.
What company makes Crosperio OTW?
Crosperio OTW is manufactured by KANEKA Corporation.
What is the FDA product code for Crosperio OTW?
The FDA product code for Crosperio OTW is LIT.
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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.