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FDA 510(k)

Ascblue (8010)

K-Number: K253777 · 2026-04-10

ApplicantAscblue Corporation
Decision Date2026-04-10
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Ascblue (8010) is a medical device manufactured by Ascblue Corporation. It received FDA 510(k) clearance on 2026-04-10 under approval number K253777. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Ascblue (8010)?

Ascblue (8010) is a medical device that received FDA 510(k) clearance on 2026-04-10. It is manufactured by Ascblue Corporation. The 510(k) number is K253777.

When was Ascblue (8010) approved by the FDA?

Ascblue (8010) received FDA 510(k) clearance on 2026-04-10, under approval number K253777.

What company makes Ascblue (8010)?

Ascblue (8010) is manufactured by Ascblue Corporation.

What is the FDA product code for Ascblue (8010)?

The FDA product code for Ascblue (8010) is GEI.

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Official Source

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