Cleared Traditional

K062937 - TRANSDISCAL SYSTEM, MODELS TDP-17-150-6, TDI-17-150, TDA-PPU-1, TDA-TBK-1, TDX-Y-TSW-TDP, TDX-PMG-PPU (FDA 510(k) Clearance)

Class II Neurology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K062937 · Baylis Medical Co., Inc. · Neurology device
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Jan 2007
Decision
102d
Days
Class 2
Risk

K062937 is an FDA 510(k) clearance for the TRANSDISCAL SYSTEM, MODELS TDP-17-150-6, TDI-17-150, TDA-PPU-1, TDA-TBK-1, TD.... 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 January 8, 2007 after a review of 102 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Baylis Medical Co., Inc. devices

Submission Details

510(k) Number K062937 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 2006
Decision Date January 08, 2007
Days to Decision 102 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
46d faster than avg
Panel avg: 148d · This submission: 102d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K062937.
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