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FDA 510(k)

Aster

K-Number: K254182 · 2026-02-26

ApplicantOsteonic Co., Ltd.
Decision Date2026-02-26
Product CodeKWQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Aster is a medical device manufactured by Osteonic Co., Ltd.. It received FDA 510(k) clearance on 2026-02-26 under approval number K254182. The device is classified under product code KWQ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Aster?

Aster is a medical device that received FDA 510(k) clearance on 2026-02-26. It is manufactured by Osteonic Co., Ltd.. The 510(k) number is K254182.

When was Aster approved by the FDA?

Aster received FDA 510(k) clearance on 2026-02-26, under approval number K254182.

What company makes Aster?

Aster is manufactured by Osteonic Co., Ltd..

What is the FDA product code for Aster?

The FDA product code for Aster is KWQ.

Other Devices by Osteonic Co., Ltd.

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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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