Cleared Traditional

K021942 - RADIONICS POLE NEEDLES

K021942 is an FDA 510(k) clearance for RADIONICS POLE NEEDLES, manufactured by Radionics, A Division of Tyco Healthcare Group LP. The device is a Class 2 Neurology device with product code GXI cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K021942 · Radionics, A Division of Tyco Healthcare Group LP · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2002
Decision
90d
Days
Class 2
Risk

K021942 is an FDA 510(k) clearance for the RADIONICS POLE NEEDLES. Classified as Probe, Radiofrequency Lesion (product code GXI), Class II - Special Controls.

Submitted by Radionics, A Division of Tyco Healthcare Group LP (Burlington, US). The FDA issued a Cleared decision on September 11, 2002 after a review of 90 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 Radionics, A Division of Tyco Healthcare Group LP devices

FDA 510(k) Submission Details - K021942

510(k) Number K021942 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 13, 2002
Decision Date September 11, 2002
Days to Decision 90 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
58d faster than avg
Panel avg: 148d · This submission: 90d
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 Peers - GXI Probe, Radiofrequency Lesion

All 38
Devices cleared under the same product code (GXI) and FDA review panel - the closest regulatory comparables to K021942.
STRYKER RF COAXIAL BIPOLAR ELECTRODES & CANNULAE
K043442 · Stryker Instruments · May 2005
STRYKER RF ELECTRODES AND CANNULAE
K032406 · Stryker Instruments · Apr 2004
SMITH & NEPHEW RF DENERVATION PROBES & RF CANNULAE
K034012 · Smith & Nephew, Inc. · Mar 2004
BAYLIS PAIN MANAGEMENT PROBE/PMP-20-145 AND BAYLIS PAIN MANAGEMENT CONNECTOR CABLE/PMX-BAY-BAY
K002389 · Baylis Medical Co., Inc. · Oct 2000
ARTHROCARE SYSTEM 2000 CONTROLLER, ARTHROCARE SYSTEM 2000 CABLE, ARTHROCARE SYSTEM 2000 FOOTSWITCH, ARTHROCARE SYSTEM 20
K001588 · Arthrocare Corp. · Aug 2000
RADIONICS MICROELECTRODE KIT
K991399 · Radionics, Inc. · Sep 1999