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Cryo-Touch II

by Myoscience, Inc.

510(k) K102021

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 · Special NumberK102021 Date17 Sep 2010ClearedStatusActive

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  • Withdrawn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 Cryo-Touch II is a hand-held, single-patient-use disposable cryogenic device classified under Device, Surgical, Cryogenic. It is designed to destroy nervous tissue or produce lesions in peripheral nervous tissue by applying controlled cold to targeted sites, primarily for pain management applications. The device operates via cryogenic freezing to achieve therapeutic effects on neural structures. Its use is supported by a 510(k) clearance (K102021) under FDA regulation 882.4250, with a classification as a Class II device and a special clearance type.

The Cryo-Touch II is intended for single-use only and is supplied sterile for direct patient application. It is regulated under the Neurology medical specialty and falls under the GXH product code. The device is not MRI-safe, and its use requires adherence to cryogenic safety protocols. Storage and handling must comply with manufacturer guidelines to maintain sterility and functionality. No additional regulatory approvals beyond the FDA 510(k) clearance are referenced in the specifications.

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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 II used for?

    The Cryo-Touch II is designed to destroy nervous tissue or create lesions in peripheral nerves by applying controlled cold. This is primarily used for pain management applications, targeting neural structures to reduce or eliminate chronic pain.

  • Is the Cryo-Touch II reusable or single-use?

    The Cryo-Touch II is intended for single-use only. It is supplied sterile and meant for direct application on one patient, ensuring safety and sterility standards are maintained.

  • How is the Cryo-Touch II supplied and stored?

    The device is supplied sterile and ready for immediate use. Proper storage and handling are critical to preserve sterility and functionality. Follow the manufacturer’s guidelines to maintain its integrity until use.

  • What safety considerations apply when using the Cryo-Touch II?

    The Cryo-Touch II requires adherence to cryogenic safety protocols during use. It is not MRI-safe, so caution must be exercised in environments where MRI scans are performed. Always follow the manufacturer’s instructions for safe operation.

  • What regulatory approval does the Cryo-Touch II hold?

    The Cryo-Touch II holds an FDA 510(k) clearance (K102021) under regulation 882.4250, classified as a Class II device with special clearance. This approval confirms its equivalence to a predicate device and compliance with U.S. regulatory standards for surgical cryogenic devices.