Magnus Neuromodulation System (MNS) with SAINT Technology, Model Number 1001K— 510(k) K220177

Name: FDA 510(k) clearance K220177
Creator: U.S. Food and Drug Administration
Published: 2022-09-01

Substantially Equivalent

Magnus Medical, Inc.

FDA 510(k) clearance K220177 for Magnus Neuromodulation System (MNS) with SAINT Technology, Model Number 1001K, Substantially Equivalent on 2022-09-01. Applicant: Magnus Medical, Inc.. Device class: 2.

Clearance details

Applicant: Magnus Medical, Inc.
Product code: Code OBP
Device class: Class 2
Regulation: 21 CFR 882.5805
Advisory panel: Neurology
Date received: 2022-01-21
Decision date: 2022-09-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Burlingame, CA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code OBP

product code OBP

Injury: 270
Total: 270

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.