Cleared Special

K053082 - BAYLIS PAIN MANAGEMENT COOLED PROBE, MODEL PMPC-18-150-6

K053082 is an FDA 510(k) clearance for BAYLIS PAIN MANAGEMENT COOLED PROBE, manufactured by Baylis Medical Co., Inc.. The device is a Class 2 Neurology device with product code GXI cleared through the Special 510(k) pathway after a 28-day FDA review.

K053082 · Baylis Medical Co., Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2005
Decision
28d
Days
Class 2
Risk

K053082 is an FDA 510(k) clearance for the BAYLIS PAIN MANAGEMENT COOLED PROBE, MODEL PMPC-18-150-6. Classified as Probe, Radiofrequency Lesion (product code GXI), Class II - Special Controls.

Submitted by Baylis Medical Co., Inc. (Mississauga, Ontario, CA). The FDA issued a Cleared decision on November 30, 2005 after a review of 28 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Baylis Medical Co., Inc. devices

FDA 510(k) Submission Details - K053082

510(k) Number K053082 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 02, 2005
Decision Date November 30, 2005
Days to Decision 28 days
Submission Type Special
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
120d faster than avg
Panel avg: 148d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

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 59
Devices cleared under the same product code (GXI) and FDA review panel - the closest regulatory comparables to K053082.
RF LESION CANNULA, RF THERMOLESION CANNULA, THERMOLESION CANNULA, X-RAY CONTRAST CANNULA, CANNULA, FACET DENERATION NEED
K060397 · PAJUNK GmbH Medizintechnologie · Aug 2006
COSMAN CSK RF CANNULA
K060799 · Cosman Medical, Inc. · May 2006
LESIONPOINT RF CANNULA
K053415 · Cosman Medical, Inc. · Apr 2006
STRYKER RF COAXIAL BIPOLAR ELECTRODES & CANNULAE
K043442 · Stryker Instruments · May 2005
COSMAN RF LESION GENERATOR, MODEL RFG-1A
K050084 · Cosman Medical, Inc. · Mar 2005
SMK, CX, CXE, RCN
K042375 · Technomed Europe · Oct 2004