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FDA 510(k)

ICEfx Cryoablation System

K-Number: K181153 · 2018-05-15

ApplicantGalil Medical, Inc.
Decision Date2018-05-15
Product CodeGEH
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ICEfx Cryoablation System is a medical device manufactured by Galil Medical, Inc.. It received FDA 510(k) clearance on 2018-05-15 under approval number K181153. The device is classified under product code GEH. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ICEfx Cryoablation System?

ICEfx Cryoablation System is a medical device that received FDA 510(k) clearance on 2018-05-15. It is manufactured by Galil Medical, Inc.. The 510(k) number is K181153.

When was ICEfx Cryoablation System approved by the FDA?

ICEfx Cryoablation System received FDA 510(k) clearance on 2018-05-15, under approval number K181153.

What company makes ICEfx Cryoablation System?

ICEfx Cryoablation System is manufactured by Galil Medical, Inc..

What is the FDA product code for ICEfx Cryoablation System?

The FDA product code for ICEfx Cryoablation System is GEH.

Related Clinical Trials

NCT06170606 POLARx Post Approval Study (POLARx PAS) ACTIVE_NOT_RECRUITING NCT04061603 iCLAS™ for Persistent Atrial Fibrillation COMPLETED NCT05416086 iCLAS™ Cryoablation System Post-Market Clinical Follow-up (PMCF) Study TERMINATED NCT06384599 VT Cryoablation System Post-Market Clinical Follow-up (PMCF) Study NOT_YET_RECRUITING NCT05675865 Cryoablation for Monomorphic Ventricular Tachycardia RECRUITING

Other Devices by Galil Medical, Inc.

K173037Visual-ICE MRI Cryoblation Console, Visual-ICE MRI Junction Box Assembly, Visual-ICE MRI Mobile Connection Panel K203032IcePearl 2.1 CX 90° Needle, IcePearl 2.1 CX L 90° Needle, IcePearl 2.1 CX Needle, IceFORCE 2.1 CX 90° Needle, IceFORCE 2.1 CX L 90° Needle, IceFORCE 2.1 CX Needle K200061HEATfx Microwave Ablation System, HEATfx Microwave Ablation System Cart, HEATfx 2.1 Needle, HEATfx 2.1 S Needle, Multi-Point Thermal Sensor (MTS)

Related Devices (Code: GEH)

K162695truFreeze SystemCSA Medical, Inc. K162599IcePearl 2.1 CX L, IceForce 2.1 CX LGalil Medical , Ltd. K161480R2 Dermal Cooling SystemR2 Dermatology K161294Compound W Wart Removal System Dual PowerMedtech Products, Inc. K161615AccurettH&O Equipments, Nv/Sa K161557truFreeze SystemCSA Medical, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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