Cleared Special

K101372 - DUOCOOL PAIN MANAGEMENT PROBE, MODEL OSP-17-180-20 (FDA 510(k) Clearance)

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

K101372 · Baylis Medical Co., Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2010
Decision
85d
Days
Class 2
Risk

K101372 is an FDA 510(k) clearance for the DUOCOOL PAIN MANAGEMENT PROBE, MODEL OSP-17-180-20. Classified as Probe, Radiofrequency Lesion (product code GXI), Class II - Special Controls.

Submitted by Baylis Medical Co., Inc. (Mississauga, Ontario, CA). The FDA issued a Cleared decision on August 10, 2010 after a review of 85 days - a notably fast clearance cycle.

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. 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 Baylis Medical Co., Inc. devices

Submission Details

510(k) Number K101372 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 17, 2010
Decision Date August 10, 2010
Days to Decision 85 days
Submission Type Special
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
63d faster than avg
Panel avg: 148d · This submission: 85d
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 65
Devices cleared under the same product code (GXI) and FDA review panel - the closest regulatory comparables to K101372.
Disposable Radiofrequency Cannula
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OneRF Trigeminal Nerve Radiofrequency Probes
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Disposable RF Electrode (RFDE-5/RFDE-10/RFDE-15/RFDE-20)
K242841 · Abbott Medical · May 2025
OptaBlate BVN Intraosseous Nerve Ablation System (10mm Probe Single Kit)
K250213 · Stryker Instruments · May 2025
RF Cannula
K241367 · Shanghai Samedical & Plastic Instruments Co., Ltd. · Jan 2025