iovera system
K-Number: K161835 · 2017-03-24
ApplicantMyoscience, Inc.
Decision Date2017-03-24
Product CodeGXH
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
iovera system is a medical device manufactured by Myoscience, Inc.. It received FDA 510(k) clearance on 2017-03-24 under approval number K161835. The device is classified under product code GXH. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the iovera system?
iovera system is a medical device that received FDA 510(k) clearance on 2017-03-24. It is manufactured by Myoscience, Inc.. The 510(k) number is K161835.
When was iovera system approved by the FDA?
iovera system received FDA 510(k) clearance on 2017-03-24, under approval number K161835.
What company makes iovera system?
iovera system is manufactured by Myoscience, Inc..
What is the FDA product code for iovera system?
The FDA product code for iovera system is GXH.
Related Clinical Trials
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A Prospective Study to Evaluate the Efficacy of Iovera Lumbar Medial Branch Cryoneurolysis Versus Radiofrequency Ablation for the Treatment of Chronic Low Back Pain
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NCT06340451
Study to Assess the Efficacy and Safety of Iovera®° System in Subjects With Upper Extremity Spasticity
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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.