Cleared Traditional

SENTIO MMG Gen 2 (K173526) - FDA 510(k) Clearance

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

K173526 · Medos International SARL · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2018
Decision
142d
Days
Class 2
Risk

K173526 is an FDA 510(k) clearance for the SENTIO MMG Gen 2. Classified as Neurosurgical Nerve Locator (product code PDQ), Class II - Special Controls.

Submitted by Medos International SARL (Lelocle, CH). The FDA issued a Cleared decision on April 5, 2018 after a review of 142 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 874.1820 - 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 Medos International SARL devices

Submission Details

510(k) Number K173526 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 14, 2017
Decision Date April 05, 2018
Days to Decision 142 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
6d faster than avg
Panel avg: 148d · This submission: 142d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code PDQ Neurosurgical Nerve Locator
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.1820
Definition To Locate Or Monitor Function Of Spinal Nerve Roots Or Peripheral Nerves During Neurosurgery.
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 Consultant

DePuy Synthes
Anna D'Lima

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - PDQ Neurosurgical Nerve Locator

All 22
Devices cleared under the same product code (PDQ) and FDA review panel - the closest regulatory comparables to K173526.
NAV PAK Needle, NIM NAV PAK Needle
K182662 · Boston Endo Surgical Tech, · Apr 2019
Neurosign V4 Intraoperative Nerve Monitor
K181559 · Magstim Company, Ltd. · Nov 2018
NIM PAK Needle
K180542 · Boston Endo Surgical Tech, · Aug 2018
SENTIO MMG Pedicle Access Needles
K173134 · Medos International SARL · Mar 2018
ES2 Neuromonitoring Accessory Instruments
K171807 · Stryker Corporation · Jul 2017
NuVasive Next Generation NVM5 System
K162313 · Nu Vasive, Incorporated · Mar 2017