EveryWare
K-Number: K242485 · 2025-05-20
ApplicantBreas Medical AB
Decision Date2025-05-20
Product CodeMOD
Advisory CommitteeAN
DecisionSubstantially Equivalent
Device Summary
EveryWare is a medical device manufactured by Breas Medical AB. It received FDA 510(k) clearance on 2025-05-20 under approval number K242485. The device is classified under product code MOD. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the EveryWare?
EveryWare is a medical device that received FDA 510(k) clearance on 2025-05-20. It is manufactured by Breas Medical AB. The 510(k) number is K242485.
When was EveryWare approved by the FDA?
EveryWare received FDA 510(k) clearance on 2025-05-20, under approval number K242485.
What company makes EveryWare?
EveryWare is manufactured by Breas Medical AB.
What is the FDA product code for EveryWare?
The FDA product code for EveryWare is MOD.
Other Devices by Breas Medical AB
Related Devices (Code: MOD)
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.