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Cryo-Touch IV

by Myoscience, Inc.

510(k) K123516

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

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 NumberK123516 Date10 Jan 2013ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-1781-2013 FDA Class II initiated 21 Jun 2013

    The outer box label of the product was labeled with a down revision label which did not include the US labeling requirements, specifically the symbol descriptors and also the "Caution: Federal Law (USA) restricts this device to sale by or on the order of a physician." This product was previously labeled for EU distribution only.

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  • Withdrawn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

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