Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Aura Glide (FC40)

K-Number: K252187 · 2025-12-23

Decision Date2025-12-23
Product CodeNFO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Aura Glide (FC40) is the device name listed in this FDA 510(k) record. The listed applicant is Aura Medical, LLC. It received FDA 510(k) clearance on 2025-12-23 under 510(k) 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. The listed applicant is Aura Medical, LLC. The 510(k) number is K252187.

When did Aura Glide (FC40) receive FDA 510(k) clearance?

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

Who is the listed applicant for Aura Glide (FC40)?

The FDA 510(k) record lists Aura Medical, LLC as the applicant. This does not by itself establish the device manufacturer.

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

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

Related Devices (Code: NFO)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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.