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

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..

Clearance details

Applicant: Magnus Medical, Inc.
Product code: Code OBP
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 ↗

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.