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FDA 510(k)

IceSphere 1.5 CX Cryoablation Needle

K-Number: K181741 · 2018-07-30

ApplicantGalil Medical , Ltd.
Decision Date2018-07-30
Product CodeGEH
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

IceSphere 1.5 CX Cryoablation Needle is the device name listed in this FDA 510(k) record. The listed applicant is Galil Medical , Ltd.. It received FDA 510(k) clearance on 2018-07-30 under 510(k) number K181741. 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 IceSphere 1.5 CX Cryoablation Needle?

IceSphere 1.5 CX Cryoablation Needle is a medical device that received FDA 510(k) clearance on 2018-07-30. The listed applicant is Galil Medical , Ltd.. The 510(k) number is K181741.

When did IceSphere 1.5 CX Cryoablation Needle receive FDA 510(k) clearance?

IceSphere 1.5 CX Cryoablation Needle received FDA 510(k) clearance on 2018-07-30, under 510(k) number K181741.

Who is the listed applicant for IceSphere 1.5 CX Cryoablation Needle?

The FDA 510(k) record lists Galil Medical , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IceSphere 1.5 CX Cryoablation Needle?

The FDA product code for IceSphere 1.5 CX Cryoablation Needle is GEH.

Other records listing Galil Medical , Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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 NeedleK200061HEATfx Microwave Ablation System, HEATfx Microwave Ablation System Cart, HEATfx 2.1 Needle, HEATfx 2.1 S Needle, Multi-Point Thermal Sensor (MTS)K181153ICEfx Cryoablation SystemK173037Visual-ICE MRI Cryoblation Console, Visual-ICE MRI Junction Box Assembly, Visual-ICE MRI Mobile Connection PanelK162599IcePearl 2.1 CX L, IceForce 2.1 CX L

Related Devices (Code: GEH)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261068Maverix Cryo Biopsy Probe (MCB1000);Maverix Cryo Cartridge (CC1000)Serpex MedicalK261806ERBECRYO 2 Cryosurgical Unit and AccessoriesErbe Elektromedizin GmbHK253230ERBECRYO 2 Cryosurgical Unit and Accessories: ERBECRYO 2 cryosurgical unit; Erbe Flexible CryoprobeErbe Elektromedizin GmbHK252198Advanced Cryo Skin Tag Remover (Advanced Skin Tag Remover)Medical Brands Laboratories B.V.K260377XSense Cryoablation System with CryoProbesIceCure Medical , Ltd.K251928CoolCryo - Cryoapplicator for cardiac cryoablation (CC01-01); CoolCryo - Control console for cardiac cryoablation with liquid nitrogen reservoir (CC01-21)Medinice S.A.

Official Source

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

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