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Stockert S5 System

by Sorin Group Deutschland GmbH

510(k) K060053

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

20 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 10 Oct 2026. What this means

Regulatory status

as of registry sync 10 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK060053 Date2 Jun 2006ClearedStatusActive

Recalls

20 recalls · FDA

  • 10 recalls, same reason

    • Terminated Z-1152-2012 FDA Not yet classified initiated 16 Feb 2012
    • Terminated Z-1156-2012 FDA Not yet classified initiated 16 Feb 2012
    • Terminated Z-1154-2012 FDA Not yet classified initiated 16 Feb 2012
    • Terminated Z-1158-2012 FDA Not yet classified initiated 16 Feb 2012
    • Terminated Z-1153-2012 FDA Not yet classified initiated 16 Feb 2012
    • Terminated Z-1155-2012 FDA Not yet classified initiated 16 Feb 2012
    • Terminated Z-1149-2012 FDA Not yet classified initiated 16 Feb 2012
    • Terminated Z-1150-2012 FDA Not yet classified initiated 16 Feb 2012
    • Terminated Z-1151-2012 FDA Not yet classified initiated 16 Feb 2012
    • Terminated Z-1157-2012 FDA Not yet classified initiated 16 Feb 2012

    Touch screen may be unresponsive, inhibiting user input.

  • 10 recalls, same reason

    • Terminated Z-0957-2011 FDA Unclassified (pre-2012) initiated 12 Nov 2010
    • Terminated Z-0964-2011 FDA Unclassified (pre-2012) initiated 12 Nov 2010
    • Terminated Z-0959-2011 FDA Unclassified (pre-2012) initiated 12 Nov 2010
    • Terminated Z-0965-2011 FDA Unclassified (pre-2012) initiated 12 Nov 2010
    • Terminated Z-0958-2011 FDA Unclassified (pre-2012) initiated 12 Nov 2010
    • Terminated Z-0961-2011 FDA Unclassified (pre-2012) initiated 12 Nov 2010
    • Terminated Z-0963-2011 FDA Unclassified (pre-2012) initiated 12 Nov 2010
    • Terminated Z-0962-2011 FDA Unclassified (pre-2012) initiated 12 Nov 2010
    • Terminated Z-0956-2011 FDA Unclassified (pre-2012) initiated 12 Nov 2010
    • Terminated Z-0960-2011 FDA Unclassified (pre-2012) initiated 12 Nov 2010

    Touch screen may become unresponsive, inhibiting user input.

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  • Withdrawn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
DTQ
Device Class
Class II
Regulation
21 CFR Part 870.4220
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

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