Cleared Traditional

K063489 - STRYKER INTRADISCAL RF GENERATOR

K063489 is an FDA 510(k) clearance for STRYKER INTRADISCAL RF GENERATOR, manufactured by Synergetics, Inc.. The device is a Class 2 Neurology device with product code GXD cleared through the Traditional 510(k) pathway after a 187-day FDA review.

K063489 · Synergetics, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2007
Decision
187d
Days
Class 2
Risk

K063489 is an FDA 510(k) clearance for the STRYKER INTRADISCAL RF GENERATOR. Classified as Generator, Lesion, Radiofrequency (product code GXD), Class II - Special Controls.

Submitted by Synergetics, Inc. (Valley Forge, US). The FDA issued a Cleared decision on May 23, 2007 after a review of 187 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.4400 - 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 Synergetics, Inc. devices

FDA 510(k) Submission Details - K063489

510(k) Number K063489 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 17, 2006
Decision Date May 23, 2007
Days to Decision 187 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
39d slower than avg
Panel avg: 148d · This submission: 187d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GXD Device Classification - Class 2, Special Controls

Product Code GXD Generator, Lesion, Radiofrequency
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.4400
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 - GXD Generator, Lesion, Radiofrequency

All 24
Devices cleared under the same product code (GXD) and FDA review panel - the closest regulatory comparables to K063489.
MultiGen™ 2 RF Generator System
K170242 · Stryker Corporation · May 2017
NT 2000 LESIONING GENERATOR
K111576 · Neuro Therm, Inc. · Sep 2011
STRYKER RF MULTI-LESION GENERATOR, MODEL 0406-900-000
K071482 · Synergetics, Inc. · Dec 2007
STRYKER INTERVENTIONAL PAIN RF GENERATOR
K032601 · Valley Forge Scientific Corp. · Apr 2004
BAYLIS PAIN MANAGEMENT GENERATOR (PMG), MODELS PMG-115 (DOMESTIC), PMG-230 (INTERNATIONAL)
K020354 · Baylis Medical Co., Inc. · May 2002
BAYLIS PAIN MANAGEMENT GENERATOR MODEL: PMG-115 (FOR DOMESTIC USE), PMG-230 (FOR INTERNATIONAL USE)
K002565 · Baylis Medical Co., Inc. · May 2001