Coalescent Surgical U-Clip and Accessories

• • 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

K024366 ↗

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) K040821 Active Cleared 23 Apr 2004

• 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

• Modification to Coalescent Surgical U-Clip and Accessories

  Class II

  FDA 510(k) K031623 Active Cleared 3 Jul 2003

See all devices from Coalescent Surgical →