Cleared Traditional

K060397 - RF LESION CANNULA, RF THERMOLESION CANNULA, THERMOLESION CANNULA, X-RAY CONTRAST CANNULA, CANNULA, FACET DENERATION NEED

K060397 is an FDA 510(k) clearance for RF LESION CANNULA, manufactured by PAJUNK GmbH Medizintechnologie. The device is a Class 2 Neurology device with product code GXI cleared through the Traditional 510(k) pathway after a 197-day FDA review.

K060397 · PAJUNK GmbH Medizintechnologie · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2006
Decision
197d
Days
Class 2
Risk

K060397 is an FDA 510(k) clearance for the RF LESION CANNULA, RF THERMOLESION CANNULA, THERMOLESION CANNULA, X-RAY CONTR.... Classified as Probe, Radiofrequency Lesion (product code GXI), Class II - Special Controls.

Submitted by PAJUNK GmbH Medizintechnologie (Geisingen, DE). The FDA issued a Cleared decision on August 31, 2006 after a review of 197 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 PAJUNK GmbH Medizintechnologie devices

FDA 510(k) Submission Details - K060397

510(k) Number K060397 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 15, 2006
Decision Date August 31, 2006
Days to Decision 197 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
49d slower than avg
Panel avg: 148d · This submission: 197d
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 K060397.
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
COSMAN CSK RF CANNULA
K060799 · Cosman Medical, Inc. · May 2006
LESIONPOINT RF CANNULA
K053415 · Cosman Medical, Inc. · Apr 2006
BAYLIS PAIN MANAGEMENT COOLED PROBE, MODEL PMPC-18-150-6
K053082 · Baylis Medical Co., Inc. · Nov 2005