Manan Pro-Mag Automatic Biopsy System

• • Terminated Z-2016-2010 FDA Unclassified (pre-2012) ·initiated 1 Sep 2009

  Medical Device Technologies doing business as Angiotech has conducted a recall on Angiotech Breast Localization Needles, Soft Tissue Biopsy Needles, Vascular Access Needles, Bone Biopsy Needles, Access Needles, Galactography Kit, Stabilization Needles and Needle Guides for packaging integrity.

510(k) Number

K980226 ↗

FDA Product Code

KNW

Device Class

Class II

Regulation

21 CFR Part 876.1075

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• Manan Biliary Drainage Catheter

  Class II

  FDA 510(k) K980191 Active Cleared 9 Feb 1998

• Manan D Bag

  Class II

  FDA 510(k) K980005 Active Cleared 30 Jan 1998

• Ultra-Core Biopsy Needles

  Class I

  FDA 510(k) K921418 Active Cleared 19 Jun 1992

• Techna-Cut Aspiration Needle

  Class II

  FDA 510(k) K974766 Active Cleared 8 Jan 1998

• Pbn Drainage Catheter Guidewires

  Class II

  FDA 510(k) K991097 Active Cleared 23 Apr 1999

• Md Tech Biopsy Set for Bone and Bone Marrow Open recall

  Class II

  FDA 510(k) K980196 Active Cleared 3 Feb 1998

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