Seednet Family (Seednet/Seedgold System, Cryothera System, Cryo-Hit System)

• 6 recalls, same reason

  • Completed Z-0681-2021 FDA Class II ·initiated 18 Nov 2020
  • Completed Z-0669-2021 FDA Class II ·initiated 18 Nov 2020
  • Completed Z-0680-2021 FDA Class II ·initiated 18 Nov 2020
  • Completed Z-0679-2021 FDA Class II ·initiated 18 Nov 2020
  • Completed Z-0688-2021 FDA Class II ·initiated 18 Nov 2020
  • Completed Z-0678-2021 FDA Class II ·initiated 18 Nov 2020

  Complaint trend regarding needle shaft gas leaks.

• • Terminated Z-1032-2011 FDA Unclassified (pre-2012) ·initiated 20 Dec 2010

  This voluntary correction has been initiated due to the discovery of a damaged optocoupler on one of our Presice Systems during periodic preventive maintenance. The optocoupler sends a signal across the locking mechanism in the Presice and Seednet MRI Systems, enabling the software to recognize if the channel on the system manifold is locked or unlocked. If an optocoupler is damaged or malfunction

510(k) Number

K051052 ↗

FDA Product Code

GEH

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 →