Bip Multi Modification

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K934371 ↗

FDA Product Code

KNW

Device Class

Class II

Regulation

21 CFR Part 876.1075

Advisory Committee

Gastroenterology, Urology

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

• 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

• Spacer

  Class I

  FDA 510(k) K925870 Active Cleared 19 May 1993

• Localization Wire or Marker - Surgical

  Class I

  FDA 510(k) K935457 Active Cleared 17 Feb 1994