Cleared Special

K243677 - iovera° System (FDA 510(k) Clearance)

Class II Neurology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K243677 · Pacira Biosciences, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2024
Decision
29d
Days
Class 2
Risk

K243677 is an FDA 510(k) clearance for the iovera° System. Classified as Device, Surgical, Cryogenic (product code GXH), Class II - Special Controls.

Submitted by Pacira Biosciences, Inc. (San Diego, US). The FDA issued a Cleared decision on December 26, 2024 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.4250 - the FDA neurology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Pacira Biosciences, Inc. devices

Submission Details

510(k) Number K243677 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
119d faster than avg
Panel avg: 148d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code GXH Device, Surgical, Cryogenic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.4250
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Neurology devices follow this clearance model.

Regulatory Peers - GXH Device, Surgical, Cryogenic

All 22
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