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FDA 510(k)

Aura Glide (FC40)

K-Number: K252187 · 2025-12-23

ApplicantAura Medical, LLC
Decision Date2025-12-23
Product CodeNFO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Aura Glide (FC40) is a medical device manufactured by Aura Medical, LLC. It received FDA 510(k) clearance on 2025-12-23 under approval number K252187. The device is classified under product code NFO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Aura Glide (FC40)?

Aura Glide (FC40) is a medical device that received FDA 510(k) clearance on 2025-12-23. It is manufactured by Aura Medical, LLC. The 510(k) number is K252187.

When was Aura Glide (FC40) approved by the FDA?

Aura Glide (FC40) received FDA 510(k) clearance on 2025-12-23, under approval number K252187.

What company makes Aura Glide (FC40)?

Aura Glide (FC40) is manufactured by Aura Medical, LLC.

What is the FDA product code for Aura Glide (FC40)?

The FDA product code for Aura Glide (FC40) is NFO.

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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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