Cleared Traditional

K161835 - iovera system

K161835 is an FDA 510(k) clearance for iovera system, manufactured by Myoscience, Inc.. The device is a Class 2 Neurology device with product code GXH cleared through the Traditional 510(k) pathway after a 262-day FDA review.

K161835 · Myoscience, Inc. · Neurology device
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Mar 2017
Decision
262d
Days
Class 2
Risk

K161835 is an FDA 510(k) clearance for the iovera system. Classified as Device, Surgical, Cryogenic (product code GXH), Class II - Special Controls.

Submitted by Myoscience, Inc. (Fremont, US). The FDA issued a Cleared decision on March 24, 2017 after a review of 262 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 Myoscience, Inc. devices

FDA 510(k) Submission Details - K161835

510(k) Number K161835 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 05, 2016
Decision Date March 24, 2017
Days to Decision 262 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
114d slower than avg
Panel avg: 148d · This submission: 262d
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 K161835.
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
Myoscience iovera system
K142866 · Myoscience, Inc. · Jan 2015
Atricure Cryo Module System
K142203 · AtriCure, Inc. · Nov 2014
IOVERA
K133453 · Myoscience, Inc. · Mar 2014