Molecular Flow Simulations— 510(k) K201435

Substantially Equivalent

Therataxis, LLC

FDA 510(k) clearance K201435 for Molecular Flow Simulations, Substantially Equivalent on 2021-12-03. Applicant: Therataxis, LLC.

Clearance details

Applicant: Therataxis, LLC
Product code: Code HAW
Advisory panel: Neurology
Date received: 2020-06-01
Decision date: 2021-12-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Baltimore, MD, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code HAW

product code HAW

Death: 52
Injury: 1,083
Malfunction: 17,300
Total: 18,435

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.