CytoCore— 510(k) K200278

Name: FDA 510(k) clearance K200278
Creator: U.S. Food and Drug Administration
Published: 2020-03-31

Substantially Equivalent

Praxis Medical, LLC

FDA 510(k) clearance K200278 for CytoCore, Substantially Equivalent on 2020-03-31. Applicant: Praxis Medical, LLC. Device class: 2.

Clearance details

Applicant: Praxis Medical, LLC
Product code: Code KNW
Device class: Class 2
Regulation: 21 CFR 876.1075
Advisory panel: Gastroenterology, Urology
Date received: 2020-02-04
Decision date: 2020-03-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tampa, FL, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code KNW

product code KNW

Death: 9
Injury: 965
Malfunction: 10,444
Other: 3
Total: 11,421

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.