Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

AtriCure cryoICE BOX (ACM)

K-Number: K243157 · 2024-10-29

ApplicantAtriCure, Inc.
Decision Date2024-10-29
Product CodeGXH
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

AtriCure cryoICE BOX (ACM) is a medical device manufactured by AtriCure, Inc.. It received FDA 510(k) clearance on 2024-10-29 under approval number K243157. 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 BOX (ACM)?

AtriCure cryoICE BOX (ACM) is a medical device that received FDA 510(k) clearance on 2024-10-29. It is manufactured by AtriCure, Inc.. The 510(k) number is K243157.

When was AtriCure cryoICE BOX (ACM) approved by the FDA?

AtriCure cryoICE BOX (ACM) received FDA 510(k) clearance on 2024-10-29, under approval number K243157.

What company makes AtriCure cryoICE BOX (ACM)?

AtriCure cryoICE BOX (ACM) is manufactured by AtriCure, Inc..

What is the FDA product code for AtriCure cryoICE BOX (ACM)?

The FDA product code for AtriCure cryoICE BOX (ACM) is GXH.

Other Devices by AtriCure, Inc.

K152337cryoFORM cryoICE cryoablation probe K160454AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip K153500AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove PRO V Clip K173031AtriClip LAA Exclusion System with Preloaded PRO·V Clip K172742AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (PRO2) K163261AtriClip PRO, PRO2, and PRO V LAA Exclusion System devices with preloaded Gillinov-Cosgrove Clip

View all 34 devices →

Related Devices (Code: GXH)

K161835iovera systemMyoscience, Inc. K182565AtriCure cryoICE cryoSPHERE cryoablation probeAtriCure, 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.

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.

↑