Seednet, Models FP6T5, FP5T5, FP5T3

• • Completed Z-0687-2021 FDA Class II ·initiated 18 Nov 2020

  Complaint trend regarding needle shaft gas leaks.

• • Terminated Z-0832-2011 FDA Unclassified (pre-2012) ·initiated 11 Nov 2010

  This voluntary recall has been initiated because our supplier (Gaymar Industries, Inc.) notified us that these products contain power cords that may crack or fail at or inside the plug due to a prong design problem. Affected plugs can be identified by a round ground pin and black plastic bridges. Cords with plugs that are not affected have U-shaped ground pins and no plastic bridges. Although Gali

510(k) Number

K010991 ↗

FDA Product Code

GEH

Models / Variants

FP6T5

FP5T5

FP5T3

FDA applicant

Galil Medical , Ltd.

Device Class

Class II

Regulation

21 CFR Part 878.4350

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Cryo-Hit Ii, Models EP3T3, EP5T2, EP5T5, EP7T5, EP8T5

  Class II

  FDA 510(k) K991517 Active Cleared 27 Jul 1999

• Seednet Gold with Renal Kit, Model Fprpr 3021, (Renal Kit), Fprch 2024 (Seednetgold)

  Class II

  FDA 510(k) K042667 Active Cleared 14 Oct 2004

• IceEdge 2.4 Cryoablation Needle

  Class II

  FDA 510(k) K111859 Active Cleared 7 Oct 2011

• Visual-Ice Cryoablation System

  Class II

  FDA 510(k) K123865 Active Cleared 6 Feb 2013

• Seednet System and Seednetgold System, Models GP6T5, GP5T5, GP5T3, HP5T5 & HP5T3

  Class II

  FDA 510(k) K021261 Active Cleared 3 Jul 2002

• ICEfx Cryoablation System

  Class II

  FDA 510(k) K181153 Active Cleared 15 May 2018

See all devices from Galil Medical Ltd →