IcePearl 2.1 CX L, IceForce 2.1 CX L
K-Number: K162599 · 2016-10-11
ApplicantGalil Medical , Ltd.
Decision Date2016-10-11
Product CodeGEH
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
IcePearl 2.1 CX L, IceForce 2.1 CX L is a medical device manufactured by Galil Medical , Ltd.. It received FDA 510(k) clearance on 2016-10-11 under approval number K162599. 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 IcePearl 2.1 CX L, IceForce 2.1 CX L?
IcePearl 2.1 CX L, IceForce 2.1 CX L is a medical device that received FDA 510(k) clearance on 2016-10-11. It is manufactured by Galil Medical , Ltd.. The 510(k) number is K162599.
When was IcePearl 2.1 CX L, IceForce 2.1 CX L approved by the FDA?
IcePearl 2.1 CX L, IceForce 2.1 CX L received FDA 510(k) clearance on 2016-10-11, under approval number K162599.
What company makes IcePearl 2.1 CX L, IceForce 2.1 CX L?
IcePearl 2.1 CX L, IceForce 2.1 CX L is manufactured by Galil Medical , Ltd..
What is the FDA product code for IcePearl 2.1 CX L, IceForce 2.1 CX L?
The FDA product code for IcePearl 2.1 CX L, IceForce 2.1 CX L 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.