FRONT-LINE Field Sterilizer (FL135)— 510(k) K243801

Substantially Equivalent

Fort Defiance Industries, LLC

FDA 510(k) clearance K243801 for FRONT-LINE Field Sterilizer (FL135), Substantially Equivalent on 2025-03-07. Applicant: Fort Defiance Industries, LLC.

Clearance details

Applicant: Fort Defiance Industries, LLC
Product code: Code FLE
Advisory panel: General Hospital
Date received: 2024-12-11
Decision date: 2025-03-07
Decision: Substantially Equivalent
Clearance type: Special
Location: Loudon, TN, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code FLE

product code FLE

Malfunction: 444
Total: 444

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.