Cleared Traditional

K173763 - iovera system (FDA 510(k) Clearance)

Class II Neurology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K173763 · Myoscience, Inc. · Neurology device
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Feb 2018
Decision
79d
Days
Class 2
Risk

K173763 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 February 28, 2018 after a review of 79 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Myoscience, Inc. devices

Submission Details

510(k) Number K173763 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 11, 2017
Decision Date February 28, 2018
Days to Decision 79 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
69d faster than avg
Panel avg: 148d · This submission: 79d
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.

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 K173763.
cryoICE cryoXT cryoablation probe (cryoXT)
K250371 · AtriCure, Inc. · Apr 2025
iovera° System
K243677 · Pacira Biosciences, Inc. · Dec 2024
AtriCure cryoICE BOX (ACM)
K243157 · AtriCure, Inc. · Oct 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