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No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K925870 ↗

FDA Product Code

MJG

Device Class

Class I

Regulation

21 CFR Part 878.4800

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Breast Stabilizer

  Class I

  FDA 510(k) K925874 Active Cleared 16 Mar 1993

• Bip Biopsy Needle Modification Open recall

  Class II

  FDA 510(k) K934370 Active Cleared 7 Mar 1994

• Bip Multi Modification

  Class II

  FDA 510(k) K934371 Active Cleared 28 Apr 1994

• Horizontal Needle Guide Attachment

  Class I

  FDA 510(k) K925875 Active Cleared 6 Apr 1993

• Vacuflash Biopsy System

  Class II

  FDA 510(k) K024089 Active Cleared 11 Mar 2003

• Localization Wire or Marker - Surgical

  Class I

  FDA 510(k) K935457 Active Cleared 17 Feb 1994