Lweet Cone Biopsy Instrument

• 8 recalls, same reason

  • Terminated Z-0617-06 FDA Unclassified (pre-2012) ·initiated 10 Mar 2006
  • Terminated Z-0620-06 FDA Unclassified (pre-2012) ·initiated 10 Mar 2006
  • Terminated Z-0618-06 FDA Unclassified (pre-2012) ·initiated 10 Mar 2006
  • Terminated Z-0616-06 FDA Unclassified (pre-2012) ·initiated 10 Mar 2006
  • Terminated Z-0619-06 FDA Unclassified (pre-2012) ·initiated 10 Mar 2006
  • Terminated Z-0615-06 FDA Unclassified (pre-2012) ·initiated 10 Mar 2006
  • Terminated Z-0621-06 FDA Unclassified (pre-2012) ·initiated 10 Mar 2006
  • Terminated Z-0614-06 FDA Unclassified (pre-2012) ·initiated 10 Mar 2006

  Change in product material may be cause for wire breaking, and tip burning and melting during procedure. Broken pieces of the device may need to be retrieved from patient.

510(k) Number

K961460 ↗

FDA Product Code

HGI

Device Class

Class II

Regulation

21 CFR Part 884.4120

Advisory Committee

Obstetrics/Gynecology

FDA Decision

SESE Substantially Equivalent

• Apple Medical Ob Mobius Elastic Retractor

  Class II

  FDA 510(k) K041131 Active Cleared 13 May 2004

• Apple Medical Mobius Elastic Retractor

  Class II

  FDA 510(k) K014005 Active Cleared 15 Feb 2002

• Fischer Cone Biopsy Excisor, Models 900-150, 151, 152, 154, 155, 157 and 158 Open recall

  Class II

  FDA 510(k) K061651 Active Cleared 20 Oct 2006

• Apple Medical/Ob Mobius Elastic Retractor

  Class I

  FDA 510(k) K050256 Active Cleared 26 Apr 2005

• The Assistant

  Class I

  FDA 510(k) K952841 Active Cleared 18 Aug 1995

• Pneumo-Matic Insufflation Needle

  Class II

  FDA 510(k) K970788 Active Cleared 27 Mar 1997

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