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 a medical device manufactured by Galil Medical , Ltd.. It received FDA 510(k) clearance on 2018-07-30 under approval 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. It is manufactured by Galil Medical , Ltd.. The 510(k) number is K181741.
When was IceSphere 1.5 CX Cryoablation Needle approved by the FDA?
IceSphere 1.5 CX Cryoablation Needle received FDA 510(k) clearance on 2018-07-30, under approval number K181741.
What company makes IceSphere 1.5 CX Cryoablation Needle?
IceSphere 1.5 CX Cryoablation Needle is manufactured by Galil Medical , Ltd..
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 Devices by Galil Medical , Ltd.
Related Devices (Code: GEH)
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.