Cleared Traditional

K123178 - STRYKER VENOM ELECTRODES AND CANNULAE

K123178 is an FDA 510(k) clearance for STRYKER VENOM ELECTRODES AND CANNULAE, manufactured by Stryker Instruments, Instruments Div.. The device is a Class 2 Neurology device with product code GXI cleared through the Traditional 510(k) pathway after a 170-day FDA review.

K123178 · Stryker Instruments, Instruments Div. · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2013
Decision
170d
Days
Class 2
Risk

K123178 is an FDA 510(k) clearance for the STRYKER VENOM ELECTRODES AND CANNULAE. Classified as Probe, Radiofrequency Lesion (product code GXI), Class II - Special Controls.

Submitted by Stryker Instruments, Instruments Div. (Kalamazoo, US). The FDA issued a Cleared decision on March 28, 2013 after a review of 170 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.

FDA 510(k) Submission Details - K123178

510(k) Number K123178 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 09, 2012
Decision Date March 28, 2013
Days to Decision 170 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
21d slower than avg
Panel avg: 149d · This submission: 170d
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 65
Devices cleared under the same product code (GXI) and FDA review panel - the closest regulatory comparables to K123178.
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K112231 · Lccs Products Limited · Aug 2011
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K102566 · Diros Technology, Inc. · Jun 2011