WestTec Procedure Facemask;WestTec Surgical Facemask— 510(k) K141085

Substantially Equivalent

Westtec, LLC

FDA 510(k) clearance K141085 for WestTec Procedure Facemask;WestTec Surgical Facemask, Substantially Equivalent on 2015-03-27. Applicant: Westtec, LLC.

Clearance details

Applicant: Westtec, LLC
Product code: Code FXX
Advisory panel: General, Plastic Surgery
Date received: 2014-04-28
Decision date: 2015-03-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kaysville, UT, US

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Adverse events under product code FXX

product code FXX

Injury: 137
Total: 137

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.