Cleared Traditional

K063489 - STRYKER INTRADISCAL RF GENERATOR

K063489 is the FDA 510(k) clearance for STRYKER INTRADISCAL RF GENERATOR by Synergetics, Inc.. It is a Class 2 Neurology device (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

Submission Details

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
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.

Device Classification

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 15
Devices cleared under the same product code (GXD) and FDA review panel - the closest regulatory comparables to K063489.
Coolief Radiofrequency Generator (CRG) System
K192491 · Avanos Medical, Inc. · Feb 2020
Polaris RF Ablation System
K181864 · Baylis Medical Company, Inc. · Jan 2019
MultiGen™ 2 RF Generator System
K170242 · Stryker Corporation · May 2017
NEURO N100 RADIOFREQUENCY GENERATOR AND ACCESSORY CABLES
K010969 · Stryker Instruments · Apr 2001
RFG-3C PLUS
K982489 · Radionics, Inc. · Oct 1998
RFG-3CF
K965182 · Radionics, Inc. · Mar 1997