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FDA 510(k)

SQUALE

K-Number: K230026 · 2023-03-28

ApplicantImplanet, S.A.
Decision Date2023-03-28
Product CodeODP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SQUALE is the device name listed in this FDA 510(k) record. The listed applicant is Implanet, S.A.. It received FDA 510(k) clearance on 2023-03-28 under 510(k) 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. The listed applicant is Implanet, S.A.. The 510(k) number is K230026.

When did SQUALE receive FDA 510(k) clearance?

SQUALE received FDA 510(k) clearance on 2023-03-28, under 510(k) number K230026.

Who is the listed applicant for SQUALE?

The FDA 510(k) record lists Implanet, S.A. as the applicant. This does not by itself establish the device manufacturer.

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.

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