Fluidshield* Surgical Mask with Expanded Chamber— 510(k) K143287

Substantially Equivalent

Halyard Health, Inc.

FDA 510(k) clearance K143287 for Fluidshield* Surgical Mask with Expanded Chamber, Substantially Equivalent on 2015-03-24. Applicant: Halyard Health, Inc..

Clearance details

Applicant: Halyard Health, Inc.
Product code: Code FXX
Advisory panel: General, Plastic Surgery
Date received: 2014-11-17
Decision date: 2015-03-24
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Alpharetta, GA, 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.