Cleared Traditional

K170242 - MultiGen™ 2 RF Generator System

K170242 is an FDA 510(k) clearance for MultiGen 2 RF Generator System, manufactured by Stryker Corporation. The device is a Class 2 Neurology device with product code GXD cleared through the Traditional 510(k) pathway after a 119-day FDA review.

K170242 · Stryker Corporation · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2017
Decision
119d
Days
Class 2
Risk

K170242 is an FDA 510(k) clearance for the MultiGen™ 2 RF Generator System. Classified as Generator, Lesion, Radiofrequency (product code GXD), Class II - Special Controls.

Submitted by Stryker Corporation (Kalamazoo, US). The FDA issued a Cleared decision on May 25, 2017 after a review of 119 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.

FDA 510(k) Submission Details - K170242

510(k) Number K170242 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 26, 2017
Decision Date May 25, 2017
Days to Decision 119 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
30d faster than avg
Panel avg: 149d · This submission: 119d
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 K170242.
Coolief Radiofrequency Generator (CRG) System
K192491 · Avanos Medical, Inc. · Feb 2020
Polaris RF Ablation System
K181864 · Baylis Medical Company, Inc. · Jan 2019
Relievant Medsystems RF Generator
K171143 · Relievant Medsystems · Aug 2017
ERASE HAND- HELD CONTROLLER
K101592 · Cheng Medical, Corporation · Oct 2011
NT 2000 LESIONING GENERATOR
K111576 · Neuro Therm, Inc. · Sep 2011
OWL UNIVERSAL RF SYSTEM URF-3AP (ML)
K093185 · Diros Technology, Inc. · Jan 2010