Cleared Traditional

K032196 - NBD DISPOSABLE RF CANNULAE

K032196 is an FDA 510(k) clearance for NBD DISPOSABLE RF CANNULAE, manufactured by New Business Development, LLC. The device is a Class 2 Neurology device with product code GXI cleared through the Traditional 510(k) pathway after a 83-day FDA review.

K032196 · New Business Development, LLC · Neurology device
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Oct 2003
Decision
83d
Days
Class 2
Risk

K032196 is an FDA 510(k) clearance for the NBD DISPOSABLE RF CANNULAE. Classified as Probe, Radiofrequency Lesion (product code GXI), Class II - Special Controls.

Submitted by New Business Development, LLC (Woodstock, US). The FDA issued a Cleared decision on October 9, 2003 after a review of 83 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K032196

510(k) Number K032196 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 18, 2003
Decision Date October 09, 2003
Days to Decision 83 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
66d faster than avg
Panel avg: 149d · This submission: 83d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 Consultant

Spectra Medical Devices, Inc.
Kathy Dassler

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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 K032196.
RF INTRODUCTION CANNULA
K041021 · Epimed International, Inc. · Sep 2004
STRYKER RF ELECTRODES AND CANNULAE
K032406 · Stryker Instruments · Apr 2004
SMITH & NEPHEW RF DENERVATION PROBES & RF CANNULAE
K034012 · Smith & Nephew, Inc. · Mar 2004
RADIONICS POLE NEEDLES
K021942 · Radionics, A Division of Tyco Healthcare Group LP · Sep 2002
NEUROTHERM, MODEL JK4
K011387 · Eurolink, LLC · Sep 2001
BAYLIS PAIN MANAGEMENT PROBE/PMP-20-145 AND BAYLIS PAIN MANAGEMENT CONNECTOR CABLE/PMX-BAY-BAY
K002389 · Baylis Medical Co., Inc. · Oct 2000
K032196 · NBD DISPOSABLE RF CANNULAE
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