Adiprep Adipose Transfer System

• • Terminated Z-0674-2017 FDA Class II ·initiated 3 Nov 2016

  Terumo BCT announces a voluntary field action for the Harvest : Adiprep Adipose Transfer System because the affected product is incorrectly labeled and has the potential for operator confusion.

510(k) Number

K121005 ↗

FDA Product Code

MUU

Device Class

Class II

Regulation

21 CFR Part 878.5040

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Smartprep Centrifuge System

  Class I

  FDA 510(k) K991430 Active Cleared 28 May 1999

• Smartjet Bone Graft Liquid Applicator (Spray Tip), Model Sk/S, Smartjet Bone Graft Liquid Applicator (Dual Lumen Cannula

  Class II

  FDA 510(k) K011032 Active Cleared 3 Jul 2001

• Smartjet Grafting Liquid Applicator, Models Sk/S & Lk/2

  Class II

  FDA 510(k) K020252 Active Cleared 5 Apr 2002

• SMARTPREP2 Centrifuge System

  Class I

  FDA 510(k) K052925 Active Cleared 4 Jan 2006

• SmartCell Processing System

  Class II

  FDA 510(k) K983022 Active Cleared 2 Apr 1999

• SMARTPREP2 Bmac System, Smartprep Platelet Concentration System

  Class I

  FDA 510(k) K103340 Active Cleared 6 Dec 2010

See all devices from Harvest Technologies, Corp. →