TENO FIX— 510(k) K023594

Name: FDA 510(k) clearance K023594
Creator: U.S. Food and Drug Administration
Published: 2003-05-15

Substantially Equivalent

Ortheon Medical, LLC

FDA 510(k) clearance K023594 for TENO FIX, Substantially Equivalent on 2003-05-15. Applicant: Ortheon Medical, LLC. Device class: 2.

Clearance details

Applicant: Ortheon Medical, LLC
Product code: Code GAQ
Device class: Class 2
Regulation: 21 CFR 878.4495
Advisory panel: General, Plastic Surgery
Date received: 2002-10-25
Decision date: 2003-05-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code GAQ

product code GAQ

Death: 3
Malfunction: 522
Total: 525

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.