Cleared Special

K243157 - AtriCure cryoICE BOX (ACM)

K243157 is an FDA 510(k) clearance for AtriCure cryoICE BOX (ACM), manufactured by AtriCure, Inc.. The device is a Class 2 Neurology device with product code GXH cleared through the Special 510(k) pathway after a 29-day FDA review.

K243157 · AtriCure, Inc. · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2024
Decision
29d
Days
Class 2
Risk

K243157 is an FDA 510(k) clearance for the AtriCure cryoICE BOX (ACM). Classified as Device, Surgical, Cryogenic (product code GXH), Class II - Special Controls.

Submitted by AtriCure, Inc. (Mason, US). The FDA issued a Cleared decision on October 29, 2024 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.4250 - the FDA neurology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K243157

510(k) Number K243157 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 2024
Decision Date October 29, 2024
Days to Decision 29 days
Submission Type Special
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
120d faster than avg
Panel avg: 149d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

GXH Device Classification - Class 2, Special Controls

Product Code GXH Device, Surgical, Cryogenic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.4250
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Neurology devices follow this clearance model.

Regulatory Peers - GXH Device, Surgical, Cryogenic

All 22
Devices cleared under the same product code (GXH) and FDA review panel - the closest regulatory comparables to K243157.
cryoICE cryoXT cryoablation probe (cryoXT)
K250371 · AtriCure, Inc. · Apr 2025
iovera° System
K243677 · Pacira Biosciences, Inc. · Dec 2024
cryoICE cryoSPHERE+ Cryoablation Probe (CRYOSP)
K233170 · AtriCure, Inc. · Oct 2023
iovera System
K220656 · Pacira Biosciences, Inc. · May 2022
Iovera System
K211334 · Pacira Pharmaceuticals, Inc. · Sep 2021
AtriCure cryoICE cryo-ablation probe (Cryo2), AAtriCure cryoICE cryoSPHERE cryoablation probe (CryoS, CryoS-L)
K200697 · AtriCure, Inc. · Dec 2020
K243157 · AtriCure cryoICE BOX (ACM)
Download PDF FDA Summary AtriCure, Inc.