Cleared Traditional

K200697 - AtriCure cryoICE cryo-ablation probe (Cryo2), AAtriCure cryoICE cryoSPHERE cryoablation probe (CryoS, CryoS-L)

K200697 is an FDA 510(k) clearance for AtriCure cryoICE cryo-ablation probe (C..., manufactured by AtriCure, Inc.. The device is a Class 2 Neurology device with product code GXH cleared through the Traditional 510(k) pathway after a 281-day FDA review.

K200697 · AtriCure, Inc. · Neurology device
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Optimized for regulatory review, auditing and printing
Dec 2020
Decision
281d
Days
Class 2
Risk

K200697 is an FDA 510(k) clearance for the AtriCure cryoICE cryo-ablation probe (Cryo2), AAtriCure cryoICE cryoSPHERE cr.... 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 December 23, 2020 after a review of 281 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.4250 - the FDA neurology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all AtriCure, Inc. devices

FDA 510(k) Submission Details - K200697

510(k) Number K200697 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 17, 2020
Decision Date December 23, 2020
Days to Decision 281 days
Submission Type Traditional
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
133d slower than avg
Panel avg: 148d · This submission: 281d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 19
Devices cleared under the same product code (GXH) and FDA review panel - the closest regulatory comparables to K200697.
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 cryoSPHERE cryoablation probe
K182565 · AtriCure, Inc. · Nov 2018
iovera system
K173763 · Myoscience, Inc. · Feb 2018
AtriCure cryoICE cryo-ablation probe (CRYO2)
K180138 · AtriCure, Inc. · Feb 2018