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Mts System, Wide-Space Quattrode Percutaneous Leads

by St. Jude Medical Neuromodulation

510(k) K123299

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

2 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 NumberK123299 Date18 Jan 2013ClearedStatusActive

Recalls

2 recalls · FDA

  • 2 recalls, same reason

    • Terminated Z-2719-2014 FDA Class II initiated 29 Jul 2014
    • Terminated Z-2718-2014 FDA Class II initiated 29 Jul 2014

    The Directions for Use (DFU) manual contains information for devices that are not approved in the US. The correct US approved versions of the manuals were sent to the customers to replace the incorrect international manuals.

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  • Withdrawn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
GZB
Device Class
Class II
Regulation
21 CFR Part 882.5880
Advisory Committee
Neurology
FDA Decision
SESE Substantially Equivalent

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