Cleared Traditional

K070336 - STOCKERT NEURO N50

K070336 is an FDA 510(k) clearance for STOCKERT NEURO N50, manufactured by Stockert GmbH. The device is a Class 2 Neurology device with product code GXD cleared through the Traditional 510(k) pathway after a 129-day FDA review.

K070336 · Stockert GmbH · Neurology device
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Jun 2007
Decision
129d
Days
Class 2
Risk

K070336 is an FDA 510(k) clearance for the STOCKERT NEURO N50, MODEL12267. Classified as Generator, Lesion, Radiofrequency (product code GXD), Class II - Special Controls.

Submitted by Stockert GmbH (Freiburg, B-W, DE). The FDA issued a Cleared decision on June 14, 2007 after a review of 129 days - within the typical 510(k) review window.

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 Stockert GmbH devices

FDA 510(k) Submission Details - K070336

510(k) Number K070336 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 05, 2007
Decision Date June 14, 2007
Days to Decision 129 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
19d faster than avg
Panel avg: 148d · This submission: 129d
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 19
Devices cleared under the same product code (GXD) and FDA review panel - the closest regulatory comparables to K070336.
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
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