Cleared Traditional

L300 Go System (K173682) - FDA 510(k) Clearance

Class II Neurology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K173682 · Bioness, Inc. · Neurology device
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Mar 2018
Decision
98d
Days
Class 2
Risk

K173682 is an FDA 510(k) clearance for the L300 Go System. Classified as Stimulator, Neuromuscular, External Functional (product code GZI), Class II - Special Controls.

Submitted by Bioness, Inc. (Valencia, US). The FDA issued a Cleared decision on March 9, 2018 after a review of 98 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5810 - 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 Bioness, Inc. devices

Submission Details

510(k) Number K173682 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 01, 2017
Decision Date March 09, 2018
Days to Decision 98 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
50d faster than avg
Panel avg: 148d · This submission: 98d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GZI Stimulator, Neuromuscular, External Functional
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5810
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 - GZI Stimulator, Neuromuscular, External Functional

All 17
Devices cleared under the same product code (GZI) and FDA review panel - the closest regulatory comparables to K173682.
L100 Go System
K200262 · Bioness, Inc. · Mar 2020
L360 Thigh System
K191587 · Bioness, Inc. · Sep 2019
L300 Go System
K190285 · Bioness, Inc. · Mar 2019
ODFS Pace XL
K171396 · Odstock Medical, Ltd. · Jan 2018
ROCHE COBAS ARGOS 5 DIFF
K912615 · Roche Diagnostic Systems, Inc. · Sep 1991
SELECT NEUROMUSCULAR STIMULATORS
K903434 · Medtronic Vascular · Aug 1991