SUPRAFLOW CONSOLE— 510(k) K040239

Substantially Equivalent

Neomedix Corp.

FDA 510(k) clearance K040239 for SUPRAFLOW CONSOLE, Substantially Equivalent on 2004-02-17. Applicant: Neomedix Corp..

Clearance details

Applicant: Neomedix Corp.
Product code: Code BTA
Advisory panel: General, Plastic Surgery
Date received: 2004-02-02
Decision date: 2004-02-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Juan Capistrano, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code BTA

product code BTA

Death: 5
Total: 5

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.