FDA 510(k)

iovera System

K-Number: K220656 · 2022-05-20

Decision Date2022-05-20

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 2022-05-20 under approval number K220656. 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 2022-05-20. It is manufactured by Pacira Biosciences, Inc.. The 510(k) number is K220656.

When was iovera System approved by the FDA?

iovera System received FDA 510(k) clearance on 2022-05-20, under approval number K220656.

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

Other Devices by Pacira Biosciences, Inc.

K243677iovera° System

Related Devices (Code: GXH)

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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.