Communicator Surgical Facemask with Clear Window— 510(k) K152561

Substantially Equivalent

Prestige Ameritech , Ltd.

FDA 510(k) clearance K152561 for Communicator Surgical Facemask with Clear Window, Substantially Equivalent on 2016-06-03. Applicant: Prestige Ameritech , Ltd..

Clearance details

Applicant: Prestige Ameritech , Ltd.
Product code: Code FXX
Advisory panel: General, Plastic Surgery
Date received: 2015-09-09
Decision date: 2016-06-03
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: North Richland Hills, TX, US

Download summary PDF View on FDA.gov ↗

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.