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Intrabeam System with Balloon Applicator and Cbg Sets

by Carl Zeiss Surgical GmbH

510(k) K090584

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

5 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 11 Oct 2026. What this means

Regulatory status

as of registry sync 11 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK090584 Date24 Nov 2009ClearedStatusActive

Recalls

5 recalls · FDA

    • Terminated Z-0001-2018 FDA Class II initiated 30 Aug 2017

    The device had an incorrect printed calibration value on the calibration certificate.

  • 3 recalls, same reason

    • Terminated Z-0404-2013 FDA Class II initiated 25 Oct 2012
    • Terminated Z-0405-2013 FDA Class II initiated 25 Oct 2012
    • Terminated Z-0406-2013 FDA Class II initiated 25 Oct 2012

    A manufacturing defect has been identified which could results in the small tube becoming dislodged between the luer fitting and the check valve.

    • Terminated Z-2989-2011 FDA Unclassified (pre-2012) initiated 1 Jul 2011

    Carl Zeiss Meditec received a report that the INTRABEAM 20 x 20 cm sterile shield's packaging looked wet inside. Investigation found the substance to be Triethylene Glycol,

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  • Withdrawn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
JAD
Device Class
Class II
Regulation
21 CFR Part 892.5900
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

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