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Myoscience iovera system

by Myoscience, Inc.

510(k) K142866

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 NumberK142866 Date21 Jan 2015ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-2201-2015 FDA Class II initiated 1 Jul 2015

    The expiration date on the outer box label and the pouch label for the iovera Smart Tip product is incorrect. Instead of indicating the correct expiration or 2015-12. the labels were incorrectly labeled 2016-05.

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  • Withdrawn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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