SEEDNET SYSTEM AND SEEDNETGOLD SYSTEM - GP5T5

• • 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

K021261 ↗

FDA Product Code

GEH

Models / Variants

GP6T5

GP5T5

GP5T3

HP5T5

HP5T3

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

• ICEfx Cryoablation System

  Class II

  FDA 510(k) K181153 Active Cleared 15 May 2018

• Seednet, Model EP6T5, EP5E5

  Class II

  FDA 510(k) K003065 Active Cleared 31 Oct 2000

See all devices from Galil Medical Ltd →