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510(k) K143564

Visual-ICE Cryoablation System, Software Revision 1.3.1 by Galil Medical, Inc. — Product Code GEH

K143564 is an FDA 510(k) premarket notification submitted by Galil Medical, Inc. for the device "Visual-ICE Cryoablation System, Software Revision 1.3.1". The FDA issued a decision of Substantially Equivalent on March 5, 2015. The device falls under product code GEH (Unit, Cryosurgical, Accessories), a Class II device regulated under 21 CFR 878.4350. Galil Medical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 5, 2015
Date Received
December 16, 2014
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Unit, Cryosurgical, Accessories
Device Class
Class II
Regulation Number
878.4350
Review Panel
SU
Submission Type

Other clearances by Galil Medical, Inc.

  • K203032 — IcePearl 2.1 CX 90° Needle, IcePearl 2.1 CX L 90° Needle, IcePearl 2.1 CX Needle (November 2, 2020)
  • K200061 — HEATfx Microwave Ablation System, HEATfx Microwave Ablation System Cart, HEATfx (July 9, 2020)
  • K181741 — IceSphere 1.5 CX Cryoablation Needle (July 30, 2018)
  • K181153 — ICEfx Cryoablation System (May 15, 2018)
  • K173037 — Visual-ICE MRI Cryoblation Console, Visual-ICE MRI Junction Box Assembly, Visual (November 21, 2017)
  • K162599 — IcePearl 2.1 CX L, IceForce 2.1 CX L (October 11, 2016)
  • K152133 — IcePearl 2.1 CX Cryoablation Needle, IcePearl 2.1 CX Prostate Cryoablation Kit V (August 28, 2015)
  • K141485 — ICESPHERE 1.5 90 CRYOBLATION NEEDLE, ICESHPERE 1.5 CYOBLATION NEEDLE (July 2, 2014)
  • K140584 — ICEROD CX CRYOABLATION NEEDLE (March 31, 2014)
  • K123865 — VISUAL-ICE CRYOABLATION SYSTEM (February 6, 2013)

Other clearances for product code GEH

  • K262420 — Maverix Cryo Biopsy Pro (MCB Pro) (MCBP-1000); Maverix Cryo Cartridge (CC-1000) (September 2, 2026)
  • K261068 — Maverix Cryo Biopsy Probe (MCB1000);Maverix Cryo Cartridge (CC1000) (June 30, 2026)
  • K261806 — ERBECRYO 2 Cryosurgical Unit and Accessories (June 9, 2026)
  • K253230 — ERBECRYO 2 Cryosurgical Unit and Accessories: ERBECRYO 2 cryosurgical unit; Erbe (April 22, 2026)
  • K252198 — Advanced Cryo Skin Tag Remover (Advanced Skin Tag Remover) (April 2, 2026)
  • K260377 — XSense Cryoablation System with CryoProbes (February 24, 2026)
  • K251928 — CoolCryo - Cryoapplicator for cardiac cryoablation (CC01-01); CoolCryo - Control (February 13, 2026)
  • K251524 — Dr. Yglo Skin Tag Remover (January 12, 2026)
  • K250742 — Focused Cryotherapy System (December 9, 2025)
  • K253000 — CryoFreeze Wart and Skin Tag Remover (October 16, 2025)

FDA data resources