Rubicor Encapsule Breast Biopsy Device, Model 31108

• • Terminated Z-0715-06 FDA Unclassified (pre-2012) ·initiated 17 Feb 2006

  Devices' sterility may be compromised due to lack of adequate sterilization.

510(k) Number

K052506 ↗

FDA Product Code

GEI

Device Class

Class II

Regulation

21 CFR Part 878.4400

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Rubicor Encapsule Breast Biopsy Device, Model 30629

  Class II

  FDA 510(k) K032584 Active Cleared 17 Sep 2003

• Rubicor Encapsule Breast Biopsy Device, Model 30086

  Class II

  FDA 510(k) K023601 Active Cleared 19 Nov 2002

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  FDA 510(k) K071048 Active Cleared 15 May 2007

• Rubicor Breast Biopsy Device

  Class II

  FDA 510(k) K020047 Active Cleared 5 Apr 2002

• Rubicor Magic Breast Biopsy Device

  Class II

  FDA 510(k) K053151 Active Cleared 18 Nov 2005

• Modification to Rubicor Encapsule Breast Biopsy Device, Model 30086

  Class II

  FDA 510(k) K030049 Active Cleared 29 Jan 2003

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