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FDA 510(k)

iovera System

K-Number: K220656 · 2022-05-20

ApplicantPacira Biosciences, Inc.
Decision Date2022-05-20
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 Biosciences, Inc.. It received FDA 510(k) clearance on 2022-05-20 under 510(k) 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. The listed applicant is Pacira Biosciences, Inc.. The 510(k) number is K220656.

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

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

Who is the listed applicant for iovera System?

The FDA 510(k) record lists Pacira Biosciences, 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.

Other records listing Pacira Biosciences, Inc. as applicant

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.

K243677iovera° System

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.K211334Iovera SystemPacira Pharmaceuticals, Inc.K200697AtriCure cryoICE cryo-ablation probe (Cryo2), AAtriCure cryoICE cryoSPHERE cryoablation probe (CryoS, CryoS-L)AtriCure, Inc.

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.

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