Cleared Traditional

K000073 - MERCURY MEDICAL DISPOSABLE RADIOFREQUEN...

K000073 is an FDA 510(k) clearance for MERCURY MEDICAL DISPOSABLE RADIOFREQUEN..., manufactured by Mercury Medical. The device is a Class 2 Neurology device with product code GXI cleared through the Traditional 510(k) pathway after a 51-day FDA review.

K000073 · Mercury Medical · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2000
Decision
51d
Days
Class 2
Risk

K000073 is an FDA 510(k) clearance for the MERCURY MEDICAL DISPOSABLE RADIOFREQUENCY CANNULA. Classified as Probe, Radiofrequency Lesion (product code GXI), Class II - Special Controls.

Submitted by Mercury Medical (Middleton, US). The FDA issued a Cleared decision on March 1, 2000 after a review of 51 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 Mercury Medical devices

FDA 510(k) Submission Details - K000073

510(k) Number K000073 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 10, 2000
Decision Date March 01, 2000
Days to Decision 51 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
97d faster than avg
Panel avg: 148d · This submission: 51d
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 39
Devices cleared under the same product code (GXI) and FDA review panel - the closest regulatory comparables to K000073.
BAYLIS PAIN MANAGEMENT PROBE/PMP-20-145 AND BAYLIS PAIN MANAGEMENT CONNECTOR CABLE/PMX-BAY-BAY
K002389 · Baylis Medical Co., Inc. · Oct 2000
ARTHROCARE SYSTEM 2000 CONTROLLER, ARTHROCARE SYSTEM 2000 CABLE, ARTHROCARE SYSTEM 2000 FOOTSWITCH, ARTHROCARE SYSTEM 20
K001588 · Arthrocare Corp. · Aug 2000
NEUROTHERM RF CANNULA
K994344 · Rocket Medical Plc · Mar 2000
RADIONICS MICROELECTRODE KIT
K991399 · Radionics, Inc. · Sep 1999
BMC RF CANNULA
K972846 · Baylis Medical Co., Inc. · Jul 1998
RADIONICS DISPOSABLE RF CANNULAE (SC-C, RFK-DB, RFK-DS)
K980430 · Radionics, Inc. · Mar 1998