Cleared Traditional

K161835 - iovera system

K161835 is the FDA 510(k) clearance for iovera system by Myoscience, Inc.. It is a Class 2 Neurology device (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

Submission Details

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
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.

Device Classification

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.