Corin BiPolar-i
K-Number: K183114 · 2019-06-05
ApplicantCorin U.S.A. Limited
Decision Date2019-06-05
Product CodeKWY
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
Corin BiPolar-i is a medical device manufactured by Corin U.S.A. Limited. It received FDA 510(k) clearance on 2019-06-05 under approval number K183114. The device is classified under product code KWY. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Corin BiPolar-i?
Corin BiPolar-i is a medical device that received FDA 510(k) clearance on 2019-06-05. It is manufactured by Corin U.S.A. Limited. The 510(k) number is K183114.
When was Corin BiPolar-i approved by the FDA?
Corin BiPolar-i received FDA 510(k) clearance on 2019-06-05, under approval number K183114.
What company makes Corin BiPolar-i?
Corin BiPolar-i is manufactured by Corin U.S.A. Limited.
What is the FDA product code for Corin BiPolar-i?
The FDA product code for Corin BiPolar-i is KWY.
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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.