Cleared Special

Iovera System

K211334 · Pacira Pharmaceuticals, Inc. · Neurology
Sep 2021
Decision
130d
Days
Class 2
Risk

About This 510(k) Submission

K211334 is an FDA 510(k) clearance for the Iovera System, a Device, Surgical, Cryogenic (Class II — Special Controls, product code GXH), submitted by Pacira Pharmaceuticals, Inc. (Fremont, US). The FDA issued a Cleared decision on September 10, 2021, 130 days after receiving the submission on May 3, 2021. This device falls under the Neurology review panel. Regulated under 21 CFR 882.4250.

Submission Details

510(k) Number K211334 FDA.gov
FDA Decision Cleared SESE
Date Received May 03, 2021
Decision Date September 10, 2021
Days to Decision 130 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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