Onera STS 2 (ONERA STS 2)
K-Number: K243220 · 2025-07-03
ApplicantOnera B.V.
Decision Date2025-07-03
Product CodeMNR
Advisory CommitteeAN
DecisionSubstantially Equivalent
Device Summary
Onera STS 2 (ONERA STS 2) is a medical device manufactured by Onera B.V.. It received FDA 510(k) clearance on 2025-07-03 under approval number K243220. The device is classified under product code MNR. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Onera STS 2 (ONERA STS 2)?
Onera STS 2 (ONERA STS 2) is a medical device that received FDA 510(k) clearance on 2025-07-03. It is manufactured by Onera B.V.. The 510(k) number is K243220.
When was Onera STS 2 (ONERA STS 2) approved by the FDA?
Onera STS 2 (ONERA STS 2) received FDA 510(k) clearance on 2025-07-03, under approval number K243220.
What company makes Onera STS 2 (ONERA STS 2)?
Onera STS 2 (ONERA STS 2) is manufactured by Onera B.V..
What is the FDA product code for Onera STS 2 (ONERA STS 2)?
The FDA product code for Onera STS 2 (ONERA STS 2) is MNR.
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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.