Cleared Traditional

K982489 - RFG-3C PLUS

K982489 is an FDA 510(k) clearance for RFG-3C PLUS, manufactured by Radionics, Inc.. The device is a Class 2 Neurology device with product code GXD cleared through the Traditional 510(k) pathway after a 80-day FDA review.

K982489 · Radionics, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1998
Decision
80d
Days
Class 2
Risk

K982489 is an FDA 510(k) clearance for the RFG-3C PLUS. Classified as Generator, Lesion, Radiofrequency (product code GXD), Class II - Special Controls.

Submitted by Radionics, Inc. (Burlington, US). The FDA issued a Cleared decision on October 5, 1998 after a review of 80 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Radionics, Inc. devices

FDA 510(k) Submission Details - K982489

510(k) Number K982489 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 17, 1998
Decision Date October 05, 1998
Days to Decision 80 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
68d faster than avg
Panel avg: 148d · This submission: 80d
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 30
Devices cleared under the same product code (GXD) and FDA review panel - the closest regulatory comparables to K982489.
BAYLIS PAIN MANAGEMENT GENERATOR MODEL: PMG-115 (FOR DOMESTIC USE), PMG-230 (FOR INTERNATIONAL USE)
K002565 · Baylis Medical Co., Inc. · May 2001
NEURO N100 RADIOFREQUENCY GENERATOR AND ACCESSORY CABLES
K010969 · Stryker Instruments · Apr 2001
RITA RF GENERATOR AND ACCESSORIES, MODEL 500 SERIES
K983214 · Rita Medical Systems · Mar 2000
RFG-3CF
K965182 · Radionics, Inc. · Mar 1997
RADIONICS SLUIJTER-MEHTA CANNULA
K963577 · Radionics, Inc. · Nov 1996
LEKSELL NEURO GENERATOR AND ACCESSORIES
K941823 · Elekta Instruments, Inc. · Mar 1996