Modification to Coalescent Surgical U-Clip and Accessories

• • Terminated Z-2030-2010 FDA Unclassified (pre-2012) ·initiated 2 Apr 2010

  Medtronic received reports involving the V100D U-Clip where during handling, the release mechanism has become separated from the needle assembly. These instances of separation have occurred when pulling the clip through prosthetic material, or when grasping and releasing the clip using robotic instrumentation. While this issue does not impact performance of the clip once implanted, separation of

• • Terminated Z-1609-2008 FDA Unclassified (pre-2012) ·initiated 25 Feb 2008

  Medtronic has identified one lot #0610315 of U-Clip Removal Tools, Catalog UREM1860FW, that was incorrectly assembled. The nose cone attachment, on the body of the removal tool, may not contain sufficient adhesive, which can allow the nose cone to separate from the body of the device.

• • Terminated Z-0968-2007 FDA Unclassified (pre-2012) ·initiated 8 Feb 2007

  Six lots of U-Clip Removal Tools, catalog REM1860FW were incorrectly assembled. The nose cone attachment to the body of the removal tool does not contain sufficient adhesive which can cause the nose to separate from the body of the device.

• • Terminated Z-0763-06 FDA Unclassified (pre-2012) ·initiated 1 Sep 2005

  Customers stated that the U-Clip deployment collar was either difficult to rotate or 'locks up' during usage, which prevents the deployment of the U-Clips.

510(k) Number

K031623 ↗

FDA Product Code

FZP

Device Class

Class II

Regulation

21 CFR Part 878.4300

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Coalescent Surgical U-Clip - or Other Tbd and Accessories

  Class II

  FDA 510(k) K021407 Active Cleared 3 Jul 2002

• Coalescent U-Clip Delivery and Disposal Device

  Class II

  FDA 510(k) K003958 Active Cleared 6 Feb 2001

• Coalescent Surgical U-Clip and Accessories

  Class II

  FDA 510(k) K024366 Active Cleared 17 Jan 2003

• Coalescent Surgical Sutured-Clip

  Class II

  FDA 510(k) K994160 Active Cleared 4 Feb 2000

• Coalescent Surgical U-Clip

  Class II

  FDA 510(k) K013664 Active Cleared 24 Jan 2002

• Coalescent U-Clip- and Accessories

  Class II

  FDA 510(k) K023125 Active Cleared 18 Dec 2002

See all devices from Coalescent Surgical →