Decision Date2026-05-29
Product CodeIRP
Advisory CommitteePM
DecisionSubstantially Equivalent
Device Summary
Cryo Sport 2.0 (AVA 501) is the device name listed in this FDA 510(k) record. The listed applicant is Avanutri Equipamentos DE Saúde. It received FDA 510(k) clearance on 2026-05-29 under 510(k) number K252396. The device is classified under product code IRP. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Cryo Sport 2.0 (AVA 501)?
Cryo Sport 2.0 (AVA 501) is a medical device that received FDA 510(k) clearance on 2026-05-29. The listed applicant is Avanutri Equipamentos DE Saúde. The 510(k) number is K252396.
When did Cryo Sport 2.0 (AVA 501) receive FDA 510(k) clearance?
Cryo Sport 2.0 (AVA 501) received FDA 510(k) clearance on 2026-05-29, under 510(k) number K252396.
Who is the listed applicant for Cryo Sport 2.0 (AVA 501)?
The FDA 510(k) record lists Avanutri Equipamentos DE Saúde as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Cryo Sport 2.0 (AVA 501)?
The FDA product code for Cryo Sport 2.0 (AVA 501) is IRP.
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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.