Banyan USA Surgical Mask Level 3— 510(k) K211097

Substantially Equivalent

Banyan USA, LLC

FDA 510(k) clearance K211097 for Banyan USA Surgical Mask Level 3, Substantially Equivalent on 2021-09-22. Applicant: Banyan USA, LLC.

Clearance details

Applicant: Banyan USA, LLC
Product code: Code FXX
Advisory panel: General, Plastic Surgery
Date received: 2021-04-13
Decision date: 2021-09-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hauppauge, NY, 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.