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FDA 510(k)

cryoFORM cryoICE cryoablation probe

K-Number: K152337 · 2016-03-22

ApplicantAtriCure, Inc.
Decision Date2016-03-22
Product CodeGEH
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

cryoFORM cryoICE cryoablation probe is a medical device manufactured by AtriCure, Inc.. It received FDA 510(k) clearance on 2016-03-22 under approval number K152337. 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 cryoFORM cryoICE cryoablation probe?

cryoFORM cryoICE cryoablation probe is a medical device that received FDA 510(k) clearance on 2016-03-22. It is manufactured by AtriCure, Inc.. The 510(k) number is K152337.

When was cryoFORM cryoICE cryoablation probe approved by the FDA?

cryoFORM cryoICE cryoablation probe received FDA 510(k) clearance on 2016-03-22, under approval number K152337.

What company makes cryoFORM cryoICE cryoablation probe?

cryoFORM cryoICE cryoablation probe is manufactured by AtriCure, Inc..

What is the FDA product code for cryoFORM cryoICE cryoablation probe?

The FDA product code for cryoFORM cryoICE cryoablation probe 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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