Skip to content

iovera system

by Myoscience, Inc. 2 variants

510(k) K173763

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK173763 Date28 Feb 2018ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
GXH
Device Class
Class II
Regulation
21 CFR Part 882.4250
Advisory Committee
Neurology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 6 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The iovera system is a surgical cryogenic device classified under device class 2, intended for use in neurology-related applications. It is a handheld system designed to target specific nerves using cryoneurolysis technology.

The device is intended for use by or under the direction of a physician in settings such as a physician's office, ambulatory surgery center (ASC), or hospital-based outpatient department (HOPD). It is used across operative and non-operative treatment pathways in specialties including orthopedics, sports medicine, anesthesia, and pain management.

Other devices from Myoscience, Inc.

See all devices from Myoscience, Inc. →

Questions

AI-generated answers, 6 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the iovera system used for?

    The iovera system is intended for use in neurology-related applications, targeting specific nerves using cryoneurolysis technology across operative and non-operative treatment pathways in specialties including orthopedics, sports medicine, anesthesia, and pain management.

  • Who can operate the iovera system and where is it used?

    The device is intended for use by or under the direction of a physician in settings such as a physician's office, ambulatory surgery center (ASC), or hospital-based outpatient department (HOPD).

  • What type of device is the iovera system and how is it designed?

    The iovera system is a handheld surgical cryogenic device classified under device class 2, designed to target specific nerves using cryoneurolysis technology.