Manual Bone Marrow Biopsy Device

• • Terminated Z-0272-2009 FDA Unclassified (pre-2012) ·initiated 27 Aug 2008

  The kits were manufactured in 2005 with syringes that expire on 10/2009 and labeled with an overall expiration on 10/2010.

510(k) Number

K993435 ↗

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. →