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Spherz

by I.Z.I. Corp. 510(k)

Active United States

510(k) K022074

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK022074 Date13 Aug 2002ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

25 recalls · FDA

  • 25 recalls, same reason

    • Terminated Z-1587-2014 FDA Class II initiated 24 Apr 2014
    • Terminated Z-1581-2014 FDA Class II initiated 24 Apr 2014
    • Terminated Z-1582-2014 FDA Class II initiated 24 Apr 2014
    • Terminated Z-1600-2014 FDA Class II initiated 24 Apr 2014
    • Terminated Z-1584-2014 FDA Class II initiated 24 Apr 2014
    • Terminated Z-1601-2014 FDA Class II initiated 24 Apr 2014
    • Terminated Z-1578-2014 FDA Class II initiated 24 Apr 2014
    • Terminated Z-1580-2014 FDA Class II initiated 24 Apr 2014
    • Terminated Z-1591-2014 FDA Class II initiated 24 Apr 2014
    • Terminated Z-1590-2014 FDA Class II initiated 24 Apr 2014
    • Terminated Z-1595-2014 FDA Class II initiated 24 Apr 2014
    • Terminated Z-1594-2014 FDA Class II initiated 24 Apr 2014
    • Terminated Z-1593-2014 FDA Class II initiated 24 Apr 2014
    • Terminated Z-1596-2014 FDA Class II initiated 24 Apr 2014
    • Terminated Z-1598-2014 FDA Class II initiated 24 Apr 2014
    • Terminated Z-1592-2014 FDA Class II initiated 24 Apr 2014
    • Terminated Z-1589-2014 FDA Class II initiated 24 Apr 2014
    • Terminated Z-1585-2014 FDA Class II initiated 24 Apr 2014
    • Terminated Z-1579-2014 FDA Class II initiated 24 Apr 2014
    • Terminated Z-1602-2014 FDA Class II initiated 24 Apr 2014
    • Terminated Z-1583-2014 FDA Class II initiated 24 Apr 2014 via K022074, on the same 510(k)
    • Terminated Z-1599-2014 FDA Class II initiated 24 Apr 2014
    • Terminated Z-1588-2014 FDA Class II initiated 24 Apr 2014 via K022074, on the same 510(k)
    • Terminated Z-1597-2014 FDA Class II initiated 24 Apr 2014
    • Terminated Z-1586-2014 FDA Class II initiated 24 Apr 2014

    Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure sterility.

Recalls marked "via" name another device cleared under the same FDA submission as this one.

Specification

510(k)

510(k) Number
FDA Product Code
HAW
Device Class
Class II
Regulation
21 CFR Part 882.4560
Advisory Committee
Neurology
FDA Decision
SESE Substantially Equivalent

Other devices from I.Z.I. Corp.