iovera° System
K-Number: K243677 · 2024-12-26
ApplicantPacira Biosciences, Inc.
Decision Date2024-12-26
Product CodeGXH
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
iovera° System is a medical device manufactured by Pacira Biosciences, Inc.. It received FDA 510(k) clearance on 2024-12-26 under approval number K243677. 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 2024-12-26. It is manufactured by Pacira Biosciences, Inc.. The 510(k) number is K243677.
When was iovera° System approved by the FDA?
iovera° System received FDA 510(k) clearance on 2024-12-26, under approval number K243677.
What company makes iovera° System?
iovera° System is manufactured by Pacira Biosciences, Inc..
What is the FDA product code for iovera° System?
The FDA product code for iovera° System is GXH.
Related Clinical Trials
NCT07214844
A Prospective Study to Evaluate the Efficacy of Iovera Lumbar Medial Branch Cryoneurolysis Versus Radiofrequency Ablation for the Treatment of Chronic Low Back Pain
RECRUITING
NCT06340451
Study to Assess the Efficacy and Safety of Iovera®° System in Subjects With Upper Extremity Spasticity
RECRUITING
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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.