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Medtronic M2 Magnet Adjustment Tool

by Medtronic Neurosurgery

510(k) K052386

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK052386 Date16 Dec 2005ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 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  • Withdrawn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
JXG
Device Class
Class II
Regulation
21 CFR Part 882.5550
Advisory Committee
Neurology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 25 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 Medtronic M2 Magnet Adjustment Tool is a magnetic tool used to non-invasively adjust the Strata-type valve when a stronger magnet is warranted by the surgeon. It is classified as a Shunt, Central Nervous System And Components device under regulation number 882.5550 and is designated for use in neurology.

The device is supplied as a reusable tool and is intended for use in clinical settings to adjust cerebrospinal fluid shunt valves. It received FDA 510(k) clearance (K052386) through the Traditional pathway on December 16, 2005, and is classified as a Class 2 device with product code JXG.

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