Cleared Special

iovera? System

K243677 · Pacira Biosciences, Inc. · Neurology
Dec 2024
Decision
29d
Days
Class 2
Risk

About This 510(k) Submission

K243677 is an FDA 510(k) clearance for the iovera? System, a Device, Surgical, Cryogenic (Class II — Special Controls, product code GXH), submitted by Pacira Biosciences, Inc. (San Diego, US). The FDA issued a Cleared decision on December 26, 2024, 29 days after receiving the submission on November 27, 2024. This device falls under the Neurology review panel. Regulated under 21 CFR 882.4250.

Submission Details

510(k) Number K243677 FDA.gov
FDA Decision Cleared SESE
Date Received November 27, 2024
Decision Date December 26, 2024
Days to Decision 29 days
Submission Type Special
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code GXH — Device, Surgical, Cryogenic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.4250

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