Cleared Special

K010969 - NEURO N100 RADIOFREQUENCY GENERATOR AND...

K010969 is the FDA 510(k) clearance for NEURO N100 RADIOFREQUENCY GENERATOR AND... by Stryker Instruments. It is a Class 2 Neurology device (product code GXD) cleared through the Special 510(k) pathway after a 18-day FDA review.

K010969 · Stryker Instruments · Neurology device
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Apr 2001
Decision
18d
Days
Class 2
Risk

K010969 is an FDA 510(k) clearance for the NEURO N100 RADIOFREQUENCY GENERATOR AND ACCESSORY CABLES. Classified as Generator, Lesion, Radiofrequency (product code GXD), Class II - Special Controls.

Submitted by Stryker Instruments (Kalamazoo, US). The FDA issued a Cleared decision on April 20, 2001 after a review of 18 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.4400 - the FDA neurology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Stryker Instruments devices

Submission Details

510(k) Number K010969 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 02, 2001
Decision Date April 20, 2001
Days to Decision 18 days
Submission Type Special
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
130d faster than avg
Panel avg: 148d · This submission: 18d
Pathway characteristics
Modification to existing cleared device.

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 14
Devices cleared under the same product code (GXD) and FDA review panel - the closest regulatory comparables to K010969.
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
RFG-3C PLUS
K982489 · Radionics, Inc. · Oct 1998
RFG-3CF
K965182 · Radionics, Inc. · Mar 1997
RADIONICS SLUIJTER-MEHTA CANNULA
K963577 · Radionics, Inc. · Nov 1996