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FDA 510(k)

AtriCure cryoICE cryo-ablation probe (Cryo2), AAtriCure cryoICE cryoSPHERE cryoablation probe (CryoS, CryoS-L)

K-Number: K200697 · 2020-12-23

ApplicantAtriCure, Inc.
Decision Date2020-12-23
Product CodeGXH
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

AtriCure cryoICE cryo-ablation probe (Cryo2), AAtriCure cryoICE cryoSPHERE cryoablation probe (CryoS, CryoS-L) is a medical device manufactured by AtriCure, Inc.. It received FDA 510(k) clearance on 2020-12-23 under approval number K200697. 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 cryo-ablation probe (Cryo2), AAtriCure cryoICE cryoSPHERE cryoablation probe (CryoS, CryoS-L)?

AtriCure cryoICE cryo-ablation probe (Cryo2), AAtriCure cryoICE cryoSPHERE cryoablation probe (CryoS, CryoS-L) is a medical device that received FDA 510(k) clearance on 2020-12-23. It is manufactured by AtriCure, Inc.. The 510(k) number is K200697.

When was AtriCure cryoICE cryo-ablation probe (Cryo2), AAtriCure cryoICE cryoSPHERE cryoablation probe (CryoS, CryoS-L) approved by the FDA?

AtriCure cryoICE cryo-ablation probe (Cryo2), AAtriCure cryoICE cryoSPHERE cryoablation probe (CryoS, CryoS-L) received FDA 510(k) clearance on 2020-12-23, under approval number K200697.

What company makes AtriCure cryoICE cryo-ablation probe (Cryo2), AAtriCure cryoICE cryoSPHERE cryoablation probe (CryoS, CryoS-L)?

AtriCure cryoICE cryo-ablation probe (Cryo2), AAtriCure cryoICE cryoSPHERE cryoablation probe (CryoS, CryoS-L) is manufactured by AtriCure, Inc..

What is the FDA product code for AtriCure cryoICE cryo-ablation probe (Cryo2), AAtriCure cryoICE cryoSPHERE cryoablation probe (CryoS, CryoS-L)?

The FDA product code for AtriCure cryoICE cryo-ablation probe (Cryo2), AAtriCure cryoICE cryoSPHERE cryoablation probe (CryoS, CryoS-L) is GXH.

Related Clinical Trials

NCT06170606 POLARx Post Approval Study (POLARx PAS) ACTIVE_NOT_RECRUITING NCT03503643 Hemi-Gland Cryoablation for Prostate Cancer at UCLA COMPLETED NCT04061603 iCLAS™ for Persistent Atrial Fibrillation COMPLETED NCT06105606 Feasibility of the AveCure Microwave Ablation Technology for the Bronchoscopic Treatment of Malignant Central Airway Obstructions TERMINATED NCT05408754 Pulsed Field Ablation and Pulsed Field CRyoAbLation in PErsistent AtriaL FibrilLation COMPLETED NCT05281237 Avecure Flexible Microwave Ablation Probe For Lung Nodules RECRUITING

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Related Devices (Code: GXH)

K161835iovera systemMyoscience, Inc. K182565AtriCure cryoICE cryoSPHERE cryoablation probeAtriCure, Inc. K173763iovera systemMyoscience, Inc. K180138AtriCure cryoICE cryo-ablation probe (CRYO2)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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