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FDA 510(k)

AtriCure cryoICE cryoSPHERE cryoablation probe

K-Number: K182565 · 2018-11-09

ApplicantAtriCure, Inc.
Decision Date2018-11-09
Product CodeGXH
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

AtriCure cryoICE cryoSPHERE cryoablation probe is a medical device manufactured by AtriCure, Inc.. It received FDA 510(k) clearance on 2018-11-09 under approval number K182565. The device is classified under product code GXH. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AtriCure cryoICE cryoSPHERE cryoablation probe?

AtriCure cryoICE cryoSPHERE cryoablation probe is a medical device that received FDA 510(k) clearance on 2018-11-09. It is manufactured by AtriCure, Inc.. The 510(k) number is K182565.

When was AtriCure cryoICE cryoSPHERE cryoablation probe approved by the FDA?

AtriCure cryoICE cryoSPHERE cryoablation probe received FDA 510(k) clearance on 2018-11-09, under approval number K182565.

What company makes AtriCure cryoICE cryoSPHERE cryoablation probe?

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

What is the FDA product code for AtriCure cryoICE cryoSPHERE cryoablation probe?

The FDA product code for AtriCure cryoICE cryoSPHERE cryoablation probe is GXH.

Other Devices by AtriCure, Inc.

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Related Devices (Code: GXH)

K161835iovera systemMyoscience, Inc. K173763iovera systemMyoscience, Inc. K180138AtriCure cryoICE cryo-ablation probe (CRYO2)AtriCure, Inc. K200697AtriCure cryoICE cryo-ablation probe (Cryo2), AAtriCure cryoICE cryoSPHERE cryoablation probe (CryoS, CryoS-L)AtriCure, Inc. K211334Iovera SystemPacira Pharmaceuticals, Inc. K220656iovera SystemPacira Biosciences, Inc.

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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