Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Iovera System

K-Number: K211334 · 2021-09-10

ApplicantPacira Pharmaceuticals, Inc.
Decision Date2021-09-10
Product CodeGXH
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Iovera System is the device name listed in this FDA 510(k) record. The listed applicant is Pacira Pharmaceuticals, Inc.. It received FDA 510(k) clearance on 2021-09-10 under 510(k) number K211334. 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 2021-09-10. The listed applicant is Pacira Pharmaceuticals, Inc.. The 510(k) number is K211334.

When did Iovera System receive FDA 510(k) clearance?

Iovera System received FDA 510(k) clearance on 2021-09-10, under 510(k) number K211334.

Who is the listed applicant for Iovera System?

The FDA 510(k) record lists Pacira Pharmaceuticals, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Iovera System?

The FDA product code for Iovera System is GXH.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT06340451Study to Assess the Efficacy and Safety of Iovera®° System in Subjects With Upper Extremity SpasticityACTIVE_NOT_RECRUITING

Related Devices (Code: GXH)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K250371cryoICE cryoXT cryoablation probe (cryoXT)AtriCure, Inc.K243677iovera° SystemPacira Biosciences, Inc.K243157AtriCure cryoICE BOX (ACM)AtriCure, Inc.K233170cryoICE cryoSPHERE+ Cryoablation Probe (CRYOSP); cryoICE cryoSPHERE+ Cryoablation Probe (CRYOSP-L); cryoICE cryoSPHERE MAX Cryoablation Probe (CRYOSMAX); cryoICE cryoSPHERE MAX Cryoablation Probe (CRYOSMAX-L)AtriCure, Inc.K220656iovera SystemPacira Biosciences, Inc.K200697AtriCure cryoICE cryo-ablation probe (Cryo2), AAtriCure cryoICE cryoSPHERE cryoablation probe (CryoS, CryoS-L)AtriCure, Inc.

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.

↑