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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Pacira Biosciences, Inc.. It received FDA 510(k) clearance on 2024-12-26 under 510(k) 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. The listed applicant is Pacira Biosciences, Inc.. The 510(k) number is K243677.

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

iovera° System received FDA 510(k) clearance on 2024-12-26, under 510(k) number K243677.

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.

K220656iovera 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.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.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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