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FDA 510(k)

CryOmega Flexx

K-Number: K172769 · 2017-11-30

ApplicantCryoconcepts LP
Decision Date2017-11-30
Product CodeGEH
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

CryOmega Flexx is a medical device manufactured by Cryoconcepts LP. It received FDA 510(k) clearance on 2017-11-30 under approval number K172769. The device is classified under product code GEH. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CryOmega Flexx?

CryOmega Flexx is a medical device that received FDA 510(k) clearance on 2017-11-30. It is manufactured by Cryoconcepts LP. The 510(k) number is K172769.

When was CryOmega Flexx approved by the FDA?

CryOmega Flexx received FDA 510(k) clearance on 2017-11-30, under approval number K172769.

What company makes CryOmega Flexx?

CryOmega Flexx is manufactured by Cryoconcepts LP.

What is the FDA product code for CryOmega Flexx?

The FDA product code for CryOmega Flexx is GEH.

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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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