Cleared Traditional

K001588 - ARTHROCARE SYSTEM 2000 CONTROLLER, ARTHROCARE SYSTEM 2000 CABLE, ARTHROCARE SYSTEM 2000 FOOTSWITCH, ARTHROCARE SYSTEM 20

K001588 is an FDA 510(k) clearance for ARTHROCARE SYSTEM 2000 CONTROLLER, manufactured by Arthrocare Corp.. The device is a Class 2 Neurology device with product code GXI cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K001588 · Arthrocare Corp. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2000
Decision
86d
Days
Class 2
Risk

K001588 is an FDA 510(k) clearance for the ARTHROCARE SYSTEM 2000 CONTROLLER, ARTHROCARE SYSTEM 2000 CABLE, ARTHROCARE S.... Classified as Probe, Radiofrequency Lesion (product code GXI), Class II - Special Controls.

Submitted by Arthrocare Corp. (Sunnyvale, US). The FDA issued a Cleared decision on August 17, 2000 after a review of 86 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 Arthrocare Corp. devices

FDA 510(k) Submission Details - K001588

510(k) Number K001588 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 23, 2000
Decision Date August 17, 2000
Days to Decision 86 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
62d faster than avg
Panel avg: 148d · This submission: 86d
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 53
Devices cleared under the same product code (GXI) and FDA review panel - the closest regulatory comparables to K001588.
STRYKER RF ELECTRODES AND CANNULAE
K032406 · Stryker Instruments · Apr 2004
SMITH & NEPHEW RF DENERVATION PROBES & RF CANNULAE
K034012 · Smith & Nephew, Inc. · Mar 2004
BAYLIS PAIN MANAGEMENT PROBE/PMP-20-145 AND BAYLIS PAIN MANAGEMENT CONNECTOR CABLE/PMX-BAY-BAY
K002389 · Baylis Medical Co., Inc. · Oct 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