Cleared Special

K183177 - Nitinol Thermocouple (TCN) Electrode

K183177 is an FDA 510(k) clearance for Nitinol Thermocouple (TCN) Electrode, manufactured by Boston Scientific Corporation. The device is a Class 2 Neurology device with product code GXI cleared through the Special 510(k) pathway after a 112-day FDA review.

K183177 · Boston Scientific Corporation · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2019
Decision
112d
Days
Class 2
Risk

K183177 is an FDA 510(k) clearance for the Nitinol Thermocouple (TCN) Electrode. Classified as Probe, Radiofrequency Lesion (product code GXI), Class II - Special Controls.

Submitted by Boston Scientific Corporation (Valencia, US). The FDA issued a Cleared decision on March 8, 2019 after a review of 112 days - within the typical 510(k) review window.

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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K183177

510(k) Number K183177 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 16, 2018
Decision Date March 08, 2019
Days to Decision 112 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
37d faster than avg
Panel avg: 149d · This submission: 112d
Pathway characteristics
Modification to existing cleared device.

GXI Device Classification - Class 2, Special Controls

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 65
Devices cleared under the same product code (GXI) and FDA review panel - the closest regulatory comparables to K183177.
Vesta RF Cannula
K190259 · Biomerics · Feb 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
Rulo Radiofrequency Lesion Probe
K190256 · Epimed International, Inc. · Mar 2019
Intracept Intraosseous Nerve Ablation System (component Intracept RF Probe)
K180369 · Relievant Medsystems · Sep 2018
INTRACEPT Intraosseous Nerve Ablation System
K170827 · Relievant Medsystems · Aug 2017
K183177 · Nitinol Thermocouple (TCN) Electrode
Download PDF FDA Summary Boston Scientific Cor…