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FDA 510(k)

AIRO Suction Unit (AIRO-01)

K-Number: K251101 · 2025-04-26

ApplicantCro, LLC
Decision Date2025-04-26
Product CodeBTA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

AIRO Suction Unit (AIRO-01) is a medical device manufactured by Cro, LLC. It received FDA 510(k) clearance on 2025-04-26 under approval number K251101. The device is classified under product code BTA. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AIRO Suction Unit (AIRO-01)?

AIRO Suction Unit (AIRO-01) is a medical device that received FDA 510(k) clearance on 2025-04-26. It is manufactured by Cro, LLC. The 510(k) number is K251101.

When was AIRO Suction Unit (AIRO-01) approved by the FDA?

AIRO Suction Unit (AIRO-01) received FDA 510(k) clearance on 2025-04-26, under approval number K251101.

What company makes AIRO Suction Unit (AIRO-01)?

AIRO Suction Unit (AIRO-01) is manufactured by Cro, LLC.

What is the FDA product code for AIRO Suction Unit (AIRO-01)?

The FDA product code for AIRO Suction Unit (AIRO-01) is BTA.

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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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