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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Caerus Corporation. It received FDA 510(k) clearance on 2024-12-18 under 510(k) 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. The listed applicant is Caerus Corporation. The 510(k) number is K241395.

When did Active System; Avenue8 receive FDA 510(k) clearance?

Active System; Avenue8 received FDA 510(k) clearance on 2024-12-18, under 510(k) number K241395.

Who is the listed applicant for Active System; Avenue8?

The FDA 510(k) record lists Caerus Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Active System; Avenue8?

The FDA product code for Active System; Avenue8 is ILX.

Related Devices (Code: ILX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K202337Pulsed electromagnetic field wrapHi-Dow International, Inc.K190251RecoveryRxBioelectronics Corporation

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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