Vacuum Assisted Core Biopsy Device

• • Terminated Z-2285-2010 FDA Unclassified (pre-2012) ·initiated 11 Aug 2010

  The firm received a customer complaint that the a device labeled as ATEC 0912-12 was actually ATEC 0912-20.

• • Terminated Z-1160-2010 FDA Unclassified (pre-2012) ·initiated 1 Feb 2010

  The product is labeled as ATEC0909-12 but it actually contains 0909-20.

• • Terminated Z-0275-2009 FDA Unclassified (pre-2012) ·initiated 22 Sep 2008

  The distal tip of the needle may become detached and remain in the patient, requiring surgical removal.

• • Terminated Z-0362-2007 FDA Unclassified (pre-2012) ·initiated 15 Dec 2006

  The handpiece package may have an incorrect part number on the inner package. Error could result in over-penetration of the biopsy needle.

• • Terminated Z-1160-06 FDA Unclassified (pre-2012) ·initiated 25 May 2006

  Lack of assurance of sterility, as package may have a seal defect (improperly sealed primary packaging).

510(k) Number

K010400 ↗

FDA Product Code

KNW

Device Class

Class II

Regulation

21 CFR Part 876.1075

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• Automated Vitrectomy Device

  Class II

  FDA 510(k) K961078 Active Cleared 14 Jun 1996

• Chiba, Franseen, Westcott, Spinal Style Aspiration Biopsy Needle

  Class II

  FDA 510(k) K945146 Active Cleared 21 Dec 1994

• Breast Lesion Localization Needle

  Class I

  FDA 510(k) K945124 Active Cleared 22 Nov 1994

• Augastroenterology-Urology Biopsy Instrument

  Class II

  FDA 510(k) K954231 Active Cleared 22 Sep 1995

• Surgical Cutter

  Class II

  FDA 510(k) K955168 Active Cleared 22 Jan 1996

• Co-Axial Introducer Needle

  Class II

  FDA 510(k) K022634 Active Cleared 6 Nov 2002

See all devices from Promex, Inc. →