Superdimension/Bronchus 4.1

• • Terminated Z-2001-2012 FDA Class II ·initiated 18 Jun 2012 ·on shared 510(k) K052260

  superDimension, Inc., is conducting a recall of certain superDimension Systems operating Software Version 4.0 - 4.9. The affected systems are sold under the product code AAS00016-xx. The products being recalled have been found to malfunction when connected to the superDimension Locatable Guide (LG). Specifically, the Systems using Software Version 4.0-4.9 will not recognize the Locatable Guide

• • Terminated Z-0666-2007 FDA Unclassified (pre-2012) ·initiated 29 Nov 2006

  The action is being taken in response to certain incidents that have been reported to the company, one of which concerned an adverse event in which a patient incurred a pneumothorax during a procedure in which a superDimension Bronchus System was used. The biopsy results for the patient were taken from a different area than the confirmed navigation site that was indicated by the system.

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

510(k) Number

K052260 ↗

FDA Product Code

JAK

Device Class

Class II

Regulation

21 CFR Part 892.1750

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

• Superdimension Nitinol/Gold Fiducial Marker

  Class II

  FDA 510(k) K120796 Active Cleared 26 Oct 2012

• Inreach System

  Class II

  FDA 510(k) K080271 Active Cleared 31 Mar 2008

• Superdimension/Bronchus Premium

  Class II

  FDA 510(k) K052852 Active Cleared 14 Nov 2005

• Superdimension Marker Delivery Kit

  Class II

  FDA 510(k) K110093 Active Cleared 11 Feb 2011

• Modification to Inreach System

  Class II

  FDA 510(k) K081379 Active Cleared 11 Jun 2008

• Modification to Superdimension/Bronchus Premium 2

  Class II

  FDA 510(k) K071473 Active Cleared 12 Jul 2007

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