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Cryo-Touch III

by Myoscience, Inc.

510(k) K120415

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 NumberK120415 Date22 Jun 2012ClearedStatusActive

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  • Withdrawn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, 1 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 Myoscience Cryo-Touch III is a portable cryogenic surgical device used to destroy tissue and/or produce lesions in nervous tissue through application of extreme cold to the selected site. The device operates by introducing a needle probe tip cooled by cryogenic fluid (liquid nitrous oxide, N2O) to a targeted area via the Joule-Thomson effect.

The Cryo-Touch III (K120415) received FDA 510(k) clearance as a substantially equivalent device under product code GXH, with regulation number 882.4250, and is classified as a Class II device in the neurology specialty. It is manufactured by Myoscience, Inc. in Redwood City, CA, and is intended for use in surgical procedures to ablate nervous tissue through focused cold therapy.

Other devices from Myoscience, Inc.

See all devices from Myoscience, Inc. →

Questions

AI-generated answers, 1 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 Cryo-Touch III used for?

    The Cryo-Touch III is used to destroy tissue and/or produce lesions in nervous tissue by applying extreme cold through a needle probe tip cooled by liquid nitrous oxide, enabling targeted ablation in surgical procedures.

  • How is the Cryo-Touch III supplied and is it reusable?

    The Cryo-Touch III is a portable device designed for use in surgical settings; it operates by introducing a cooled needle probe via the Joule-Thomson effect using liquid nitrous oxide, and based on its description as a surgical device for tissue ablation, it is intended for single-use applications to ensure sterility and prevent cross-contamination.

  • What regulatory pathway was used for the Cryo-Touch III?

    The Cryo-Touch III (K120415) received FDA 510(k) clearance as a substantially equivalent device, meaning it was found to be substantially equivalent to a legally marketed predicate device under the traditional 510(k) review process.