Cleared Traditional

K043442 - STRYKER RF COAXIAL BIPOLAR ELECTRODES & CANNULAE

K043442 is an FDA 510(k) clearance for STRYKER RF COAXIAL BIPOLAR ELECTRODES &..., manufactured by Stryker Instruments. The device is a Class 2 Neurology device with 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

FDA 510(k) Submission Details - K043442

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.

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

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 53
Devices cleared under the same product code (GXI) and FDA review panel - the closest regulatory comparables to K043442.
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
BAYLIS PAIN MANAGEMENT COOLED PROBE, MODEL PMPC-18-150-6
K053082 · Baylis Medical Co., Inc. · Nov 2005
COSMAN RF LESION GENERATOR, MODEL RFG-1A
K050084 · Cosman Medical, Inc. · Mar 2005
SMK, CX, CXE, RCN
K042375 · Technomed Europe · Oct 2004
STRYKER RF ELECTRODES AND CANNULAE
K032406 · Stryker Instruments · Apr 2004