Cleared Traditional

K133453 - IOVERA

K133453 is an FDA 510(k) clearance for IOVERA, 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 132-day FDA review.

K133453 · Myoscience, Inc. · Neurology device
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Mar 2014
Decision
132d
Days
Class 2
Risk

K133453 is an FDA 510(k) clearance for the IOVERA. Classified as Device, Surgical, Cryogenic (product code GXH), Class II - Special Controls.

Submitted by Myoscience, Inc. (Redwood City, US). The FDA issued a Cleared decision on March 24, 2014 after a review of 132 days - within the typical 510(k) review window.

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 - K133453

510(k) Number K133453 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 12, 2013
Decision Date March 24, 2014
Days to Decision 132 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
16d faster than avg
Panel avg: 148d · This submission: 132d
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 K133453.
iovera system
K161835 · Myoscience, Inc. · Mar 2017
Myoscience iovera system
K142866 · Myoscience, Inc. · Jan 2015
Atricure Cryo Module System
K142203 · AtriCure, Inc. · Nov 2014
CRYO-TOUCH IV
K123516 · Myoscience, Inc. · Jan 2013
CRYO-TOUCH III
K120415 · Myoscience, Inc. · Jun 2012
CRYOMEDICAL INSTRUMENTS CRYO-PAC SYSTEMS
K050272 · Cryomedical Instruments, Ltd. · Mar 2005