FDA 510(k)

EmeryGlide (EG18008901)

K-Number: K253262 · 2026-03-06

Decision Date2026-03-06

Product CodeDQX

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

EmeryGlide (EG18008901) is a medical device manufactured by Nano4imaging GmbH. It received FDA 510(k) clearance on 2026-03-06 under approval number K253262. The device is classified under product code DQX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EmeryGlide (EG18008901)?

EmeryGlide (EG18008901) is a medical device that received FDA 510(k) clearance on 2026-03-06. It is manufactured by Nano4imaging GmbH. The 510(k) number is K253262.

When was EmeryGlide (EG18008901) approved by the FDA?

EmeryGlide (EG18008901) received FDA 510(k) clearance on 2026-03-06, under approval number K253262.

What company makes EmeryGlide (EG18008901)?

EmeryGlide (EG18008901) is manufactured by Nano4imaging GmbH.

What is the FDA product code for EmeryGlide (EG18008901)?

The FDA product code for EmeryGlide (EG18008901) is DQX.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.