Cleared Special

K190259 - Vesta RF Cannula

K190259 is the FDA 510(k) clearance for Vesta RF Cannula by Biomerics. It is a Class 2 Neurology device (product code GXI) cleared through the Special 510(k) pathway after a 365-day FDA review.

K190259 · Biomerics · Neurology device
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Feb 2020
Decision
365d
Days
Class 2
Risk

K190259 is an FDA 510(k) clearance for the Vesta RF Cannula. Classified as Probe, Radiofrequency Lesion (product code GXI), Class II - Special Controls.

Submitted by Biomerics (Salt Lake City, US). The FDA issued a Cleared decision on February 7, 2020 after a review of 365 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.4725 - 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. Elevated predicate reliance 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 Biomerics devices

Submission Details

510(k) Number K190259 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 07, 2019
Decision Date February 07, 2020
Days to Decision 365 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
217d slower than avg
Panel avg: 148d · This submission: 365d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code GXI Probe, Radiofrequency Lesion
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.4725
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 - GXI Probe, Radiofrequency Lesion

All 30
Devices cleared under the same product code (GXI) and FDA review panel - the closest regulatory comparables to K190259.
Intracept Intraosseous Nerve Ablation System
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Intracept Intraosseous Nerve Ablation System
K213836 · Relievant Medsystems, Inc. · Mar 2022
COOLIEF Cooled Radiofrequency Kit Advanced
K203066 · Avanos Medical, Inc. · Dec 2020
LCCS VC-S RF Cannula
K191293 · Lccs Products Limited · Jan 2020
Intracept Intraosseous Nerve Ablation System (RF Probe), Intracept Intraosseous Nerve Ablation System (Access Instruments), Relievant RF Generator
K190504 · Relievant Medsystems · May 2019
Nitinol Thermocouple (TCN) Electrode
K183177 · Boston Scientific Corporation · Mar 2019