Cleared Traditional

K032601 - STRYKER INTERVENTIONAL PAIN RF GENERATOR

K032601 is an FDA 510(k) clearance for STRYKER INTERVENTIONAL PAIN RF GENERATOR, manufactured by Valley Forge Scientific Corp.. The device is a Class 2 Neurology device with product code GXD cleared through the Traditional 510(k) pathway after a 220-day FDA review.

K032601 · Valley Forge Scientific Corp. · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2004
Decision
220d
Days
Class 2
Risk

K032601 is an FDA 510(k) clearance for the STRYKER INTERVENTIONAL PAIN RF GENERATOR. Classified as Generator, Lesion, Radiofrequency (product code GXD), Class II - Special Controls.

Submitted by Valley Forge Scientific Corp. (Oaks, US). The FDA issued a Cleared decision on April 1, 2004 after a review of 220 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 Valley Forge Scientific Corp. devices

FDA 510(k) Submission Details - K032601

510(k) Number K032601 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 25, 2003
Decision Date April 01, 2004
Days to Decision 220 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
71d slower than avg
Panel avg: 149d · This submission: 220d
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 35
Devices cleared under the same product code (GXD) and FDA review panel - the closest regulatory comparables to K032601.
OWL URF-3AP
K062758 · Diros Technology, Inc. · Sep 2006
NT-1000
K052878 · Neuro Therm, Inc. · Jan 2006
PHYSICIAN INDUSTRIES RADIOFREQUENCY ABLATION NEEDLE
K040565 · Physician Industries, Inc. · Jul 2004
OWL RADIOFREQUENCY SYSTEM, MODEL URF-2AP
K021869 · Diros Technology, Inc. · Jul 2002
BAYLIS PAIN MANAGEMENT GENERATOR (PMG), MODELS PMG-115 (DOMESTIC), PMG-230 (INTERNATIONAL)
K020354 · Baylis Medical Co., Inc. · May 2002
OWL RADIOFREQUENCY SYSTEM, MODEL URF-2A, AND ASSOCIATE RADIOFREQUENCY LESION PROBES
K010202 · Leslie W. Organ · Oct 2001