SQUALE
K-Number: K230026 · 2023-03-28
ApplicantImplanet, S.A.
Decision Date2023-03-28
Product CodeODP
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
SQUALE is a medical device manufactured by Implanet, S.A.. It received FDA 510(k) clearance on 2023-03-28 under approval number K230026. The device is classified under product code ODP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the SQUALE?
SQUALE is a medical device that received FDA 510(k) clearance on 2023-03-28. It is manufactured by Implanet, S.A.. The 510(k) number is K230026.
When was SQUALE approved by the FDA?
SQUALE received FDA 510(k) clearance on 2023-03-28, under approval number K230026.
What company makes SQUALE?
SQUALE is manufactured by Implanet, S.A..
What is the FDA product code for SQUALE?
The FDA product code for SQUALE is ODP.
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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.