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Ksea Monopolar Vaporization Electrodes

by Karl Storz Endoscopy-America, Inc. 2 variants

510(k) K983569

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

12 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 NumberK983569 Date8 Jan 1999ClearedStatusActive

Recalls

12 recalls · FDA

  • 12 recalls, same reason

    • Terminated Z-1314-2013 FDA Class II initiated 1 Jun 2009 on shared 510(k) K983569
    • Terminated Z-1308-2013 FDA Class II initiated 1 Jun 2009 on shared 510(k) K983569
    • Terminated Z-1316-2013 FDA Class II initiated 1 Jun 2009 on shared 510(k) K983569
    • Terminated Z-1315-2013 FDA Class II initiated 1 Jun 2009 on shared 510(k) K983569
    • Terminated Z-1307-2013 FDA Class II initiated 1 Jun 2009 on shared 510(k) K983569
    • Terminated Z-1305-2013 FDA Class II initiated 1 Jun 2009 on shared 510(k) K983569
    • Terminated Z-1313-2013 FDA Class II initiated 1 Jun 2009 on shared 510(k) K983569
    • Terminated Z-1306-2013 FDA Class II initiated 1 Jun 2009 on shared 510(k) K983569
    • Terminated Z-1312-2013 FDA Class II initiated 1 Jun 2009 on shared 510(k) K983569
    • Terminated Z-1310-2013 FDA Class II initiated 1 Jun 2009 on shared 510(k) K983569
    • Terminated Z-1309-2013 FDA Class II initiated 1 Jun 2009 on shared 510(k) K983569
    • Terminated Z-1311-2013 FDA Class II initiated 1 Jun 2009 on shared 510(k) K983569

    Possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products, which may result in airborne contamination.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

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  • Withdrawn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
HIH
Device Class
Class II
Regulation
21 CFR Part 884.1690
Advisory Committee
Obstetrics/Gynecology
FDA Decision
SESE Substantially Equivalent

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