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SENTIO MMG Gen 2

by Medos International SARL

510(k) K173526

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK173526 Date5 Apr 2018ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
PDQ
Device class
Class II
Regulation
21 CFR Part 874.1820
Advisory committee
Ear, Nose, Throat
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 22 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The SENTIO MMG Gen 2 is a neurosurgical nerve locator. It is designed to assist in identifying nerves during surgical procedures.

The device is supplied as a Class II medical device with product code PDQ, regulated under 21 CFR 874.1820. It is intended for use in ear, nose, and throat procedures and received FDA 510(k) clearance on April 5, 2018.

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