Cleared Traditional

K043442 - STRYKER RF COAXIAL BIPOLAR ELECTRODES &...

K043442 is the FDA 510(k) clearance for STRYKER RF COAXIAL BIPOLAR ELECTRODES &... by Stryker Instruments. It is a Class 2 Neurology device (product code GXI) cleared through the Traditional 510(k) pathway after a 168-day FDA review.

K043442 · Stryker Instruments · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2005
Decision
168d
Days
Class 2
Risk

K043442 is an FDA 510(k) clearance for the STRYKER RF COAXIAL BIPOLAR ELECTRODES & CANNULAE. Classified as Probe, Radiofrequency Lesion (product code GXI), Class II - Special Controls.

Submitted by Stryker Instruments (Kalamazoo, US). The FDA issued a Cleared decision on May 31, 2005 after a review of 168 days - an extended review 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: 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 Stryker Instruments devices

Submission Details

510(k) Number K043442 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 14, 2004
Decision Date May 31, 2005
Days to Decision 168 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
20d slower than avg
Panel avg: 148d · This submission: 168d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 Consultant

Entela, Inc.
NEIL E DEVINE

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 30
Devices cleared under the same product code (GXI) and FDA review panel - the closest regulatory comparables to K043442.
MODIFICATION TO SMITH & NEPHEW RF DENERVATION PROBES & RF CANNULAE
K071300 · Smith & Nephew, Inc. · Jul 2007
SMITH & NEPHEW RF CANNULAE
K063467 · Smith & Nephew, Inc. · Nov 2006
RF LESION CANNULA, RF THERMOLESION CANNULA, THERMOLESION CANNULA, X-RAY CONTRAST CANNULA, CANNULA, FACET DENERATION NEED
K060397 · PAJUNK GmbH Medizintechnologie · Aug 2006
STRYKER RF ELECTRODES AND CANNULAE
K032406 · Stryker Instruments · Apr 2004
SMITH & NEPHEW RF DENERVATION PROBES & RF CANNULAE
K034012 · Smith & Nephew, Inc. · Mar 2004
ARTHROCARE SYSTEM 2000 CONTROLLER, ARTHROCARE SYSTEM 2000 CABLE, ARTHROCARE SYSTEM 2000 FOOTSWITCH, ARTHROCARE SYSTEM 20
K001588 · Arthrocare Corp. · Aug 2000