Insta-Gard Surgical and Procedure Face Mask— 510(k) K142990

Substantially Equivalent

Cardinal Health200, LLC

FDA 510(k) clearance K142990 for Insta-Gard Surgical and Procedure Face Mask, Substantially Equivalent on 2015-03-04. Applicant: Cardinal Health200, LLC.

Clearance details

Applicant: Cardinal Health200, LLC
Product code: Code FXX
Advisory panel: General, Plastic Surgery
Date received: 2014-10-16
Decision date: 2015-03-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Waukegan, IL, 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.