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FDA 510(k)

Braun Aura 9 (6042)

K-Number: K261977 · 2026-09-25

ApplicantCyden Limited
Decision Date2026-09-25
Product CodeOHT
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Braun Aura 9 (6042) is the device name listed in this FDA 510(k) record. The listed applicant is Cyden Limited. It received FDA 510(k) clearance on 2026-09-25 under 510(k) number K261977. The device is classified under product code OHT. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Braun Aura 9 (6042)?

Braun Aura 9 (6042) is a medical device that received FDA 510(k) clearance on 2026-09-25. The listed applicant is Cyden Limited. The 510(k) number is K261977.

When did Braun Aura 9 (6042) receive FDA 510(k) clearance?

Braun Aura 9 (6042) received FDA 510(k) clearance on 2026-09-25, under 510(k) number K261977.

Who is the listed applicant for Braun Aura 9 (6042)?

The FDA 510(k) record lists Cyden Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Braun Aura 9 (6042)?

The FDA product code for Braun Aura 9 (6042) is OHT.

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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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