Cleared Traditional

K983214 - RITA RF GENERATOR AND ACCESSORIES, MODEL 500 SERIES

K983214 is an FDA 510(k) clearance for RITA RF GENERATOR AND ACCESSORIES, manufactured by Rita Medical Systems. The device is a Class 2 Neurology device with product code GXD cleared through the Traditional 510(k) pathway after a 560-day FDA review.

K983214 · Rita Medical Systems · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2000
Decision
560d
Days
Class 2
Risk

K983214 is an FDA 510(k) clearance for the RITA RF GENERATOR AND ACCESSORIES, MODEL 500 SERIES. Classified as Generator, Lesion, Radiofrequency (product code GXD), Class II - Special Controls.

Submitted by Rita Medical Systems (Mountain View, US). The FDA issued a Cleared decision on March 27, 2000 after a review of 560 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Neurology submissions.

View all Rita Medical Systems devices

FDA 510(k) Submission Details - K983214

510(k) Number K983214 FDA.gov
FDA Decision Cleared Substantially Equivalent - Abbreviated 510(k) (SESU)
Date Received September 14, 1998
Decision Date March 27, 2000
Days to Decision 560 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
412d slower than avg
Panel avg: 148d · This submission: 560d
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 22
Devices cleared under the same product code (GXD) and FDA review panel - the closest regulatory comparables to K983214.
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
NEURO N100 RADIOFREQUENCY GENERATOR AND ACCESSORY CABLES
K010969 · Stryker Instruments · Apr 2001
RFG-3C PLUS
K982489 · Radionics, Inc. · Oct 1998
RFG-3CF
K965182 · Radionics, Inc. · Mar 1997
RADIONICS SLUIJTER-MEHTA CANNULA
K963577 · Radionics, Inc. · Nov 1996