Vanguard Reprocessed Dilating Tip and Blunt Trocars

• • Terminated Z-1212-06 FDA Unclassified (pre-2012) ·initiated 17 Mar 2006

  Review of complaints and testing show that the distal tip of the trocars may separate while in use.

510(k) Number

K043253 ↗

FDA Product Code

NLM

Device Class

Class II

Regulation

21 CFR Part 876.1500

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• Vanguard Reprocessed Non-Electric Biopsy Forceps

  Class I

  FDA 510(k) K042594 Active Cleared 25 Jan 2005

• Vanguard Reprocessed Femoral Compression Device

  Class II

  FDA 510(k) K011832 Active Cleared 21 Dec 2001

• Vanguard Reprocessed Diagnostic Electrophysiology Catheters

  Class II

  FDA 510(k) K042074 Active Cleared 9 Mar 2005

• Vanguard Reprocessed Compression Garment

  Class II

  FDA 510(k) K012403 Active Cleared 17 Oct 2001

• Reprocessed Disposable Cutters, Staplers and Appliers

  Class II

  FDA 510(k) K032973 Active Cleared 18 Dec 2003

• Vanguard Reprocessed External Fixation Devices

  Class II

  FDA 510(k) K031687 Active Cleared 30 Apr 2004

See all devices from Vanguard Medical Concepts, Inc. →