Cleared Traditional

K171143 - Relievant Medsystems RF Generator

K171143 is the FDA 510(k) clearance for Relievant Medsystems RF Generator by Relievant Medsystems. It is a Class 2 Neurology device (product code GXD) cleared through the Traditional 510(k) pathway after a 122-day FDA review.

K171143 · Relievant Medsystems · Neurology device
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Aug 2017
Decision
122d
Days
Class 2
Risk

K171143 is an FDA 510(k) clearance for the Relievant Medsystems RF Generator. Classified as Generator, Lesion, Radiofrequency (product code GXD), Class II - Special Controls.

Submitted by Relievant Medsystems (Redwood City, US). The FDA issued a Cleared decision on August 18, 2017 after a review of 122 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 Relievant Medsystems devices

Submission Details

510(k) Number K171143 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 18, 2017
Decision Date August 18, 2017
Days to Decision 122 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
26d faster than avg
Panel avg: 148d · This submission: 122d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 15
Devices cleared under the same product code (GXD) and FDA review panel - the closest regulatory comparables to K171143.
IonicRF Generator
K201610 · Abbott Medical · Oct 2020
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
NEURO N100 RADIOFREQUENCY GENERATOR AND ACCESSORY CABLES
K010969 · Stryker Instruments · Apr 2001
RFG-3C PLUS
K982489 · Radionics, Inc. · Oct 1998