Active System; Avenue8
K-Number: K241395 · 2024-12-18
ApplicantCaerus Corporation
Decision Date2024-12-18
Product CodeILX
Advisory CommitteePM
DecisionSubstantially Equivalent
Device Summary
Active System; Avenue8 is a medical device manufactured by Caerus Corporation. It received FDA 510(k) clearance on 2024-12-18 under approval number K241395. The device is classified under product code ILX. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Active System; Avenue8?
Active System; Avenue8 is a medical device that received FDA 510(k) clearance on 2024-12-18. It is manufactured by Caerus Corporation. The 510(k) number is K241395.
When was Active System; Avenue8 approved by the FDA?
Active System; Avenue8 received FDA 510(k) clearance on 2024-12-18, under approval number K241395.
What company makes Active System; Avenue8?
Active System; Avenue8 is manufactured by Caerus Corporation.
What is the FDA product code for Active System; Avenue8?
The FDA product code for Active System; Avenue8 is ILX.
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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.