Cleared Traditional

K171143 - Relievant Medsystems RF Generator

K171143 is an FDA 510(k) clearance for Relievant Medsystems RF Generator, manufactured by Relievant Medsystems. The device is a Class 2 Neurology device with 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

FDA 510(k) Submission Details - K171143

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
Combination Product No
PCCP Authorized No
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.

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 24
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
NT 2000 LESIONING GENERATOR
K111576 · Neuro Therm, Inc. · Sep 2011
STRYKER RF MULTI-LESION GENERATOR, MODEL 0406-900-000
K071482 · Synergetics, Inc. · Dec 2007