iovera° System— 510(k) K243677

Substantially Equivalent

Pacira Biosciences, Inc.

FDA 510(k) clearance K243677 for iovera° System, Substantially Equivalent on 2024-12-26. Applicant: Pacira Biosciences, Inc.. Device class: 2.

Clearance details

Applicant: Pacira Biosciences, Inc.
Product code: Code GXH
Device class: Class 2
Regulation: 21 CFR 882.4250
Advisory panel: Neurology
Date received: 2024-11-27
Decision date: 2024-12-26
Decision: Substantially Equivalent
Clearance type: Special
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.