Cleared Traditional

K071300 - MODIFICATION TO SMITH & NEPHEW RF DENERVATION PROBES & RF CANNULAE

K071300 is an FDA 510(k) clearance for MODIFICATION TO SMITH & NEPHEW RF DENER..., manufactured by Smith & Nephew, Inc.. The device is a Class 2 Neurology device with product code GXI cleared through the Traditional 510(k) pathway after a 72-day FDA review.

K071300 · Smith & Nephew, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2007
Decision
72d
Days
Class 2
Risk

K071300 is an FDA 510(k) clearance for the MODIFICATION TO SMITH & NEPHEW RF DENERVATION PROBES & RF CANNULAE. Classified as Probe, Radiofrequency Lesion (product code GXI), Class II - Special Controls.

Submitted by Smith & Nephew, Inc. (Andover, US). The FDA issued a Cleared decision on July 20, 2007 after a review of 72 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.

View all Smith & Nephew, Inc. devices

FDA 510(k) Submission Details - K071300

510(k) Number K071300 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 09, 2007
Decision Date July 20, 2007
Days to Decision 72 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
76d faster than avg
Panel avg: 148d · This submission: 72d
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 55
Devices cleared under the same product code (GXI) and FDA review panel - the closest regulatory comparables to K071300.
DUOCOOL PAIN MANAGEMENT PROBE, MODEL OSP-17-180-20
K101372 · Baylis Medical Co., Inc. · Aug 2010
PAIN MANAGEMENT OPTIMA, MODEL PMO21-100-05, PMO20-100-10CS, PMO20-145-10CS
K092337 · Baylis Medical Co., Inc. · Oct 2009
SMITH & NEPHEW RF CANNULATE
K090955 · Smith & Nephew, Inc. · Jul 2009
BAYLIS PAIN MANAGEMENT SINGLE-USE PROBE
K071745 · Baylis Medical Co., Inc. · Jul 2007
TRANSDISCAL SYSTEM, MODELS TDP-17-150-6, TDI-17-150, TDA-PPU-1, TDA-TBK-1, TDX-Y-TSW-TDP, TDX-PMG-PPU
K062937 · Baylis Medical Co., Inc. · Jan 2007
SMITH & NEPHEW RF CANNULAE
K063467 · Smith & Nephew, Inc. · Nov 2006