Alpha Control Liner System (ACLS)
K-Number: K223738 · 2023-01-11
ApplicantCoapt
Decision Date2023-01-11
Product CodeGXY
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
Alpha Control Liner System (ACLS) is a medical device manufactured by Coapt. It received FDA 510(k) clearance on 2023-01-11 under approval number K223738. The device is classified under product code GXY. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Alpha Control Liner System (ACLS)?
Alpha Control Liner System (ACLS) is a medical device that received FDA 510(k) clearance on 2023-01-11. It is manufactured by Coapt. The 510(k) number is K223738.
When was Alpha Control Liner System (ACLS) approved by the FDA?
Alpha Control Liner System (ACLS) received FDA 510(k) clearance on 2023-01-11, under approval number K223738.
What company makes Alpha Control Liner System (ACLS)?
Alpha Control Liner System (ACLS) is manufactured by Coapt.
What is the FDA product code for Alpha Control Liner System (ACLS)?
The FDA product code for Alpha Control Liner System (ACLS) is GXY.
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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.