K111313

Substantially Equivalent

EXSEPT SKIN AND WOUND CLEANSER WITH ANTIMICROBIAL PRESERVATIVE

Applicant: Alcavis Hdc, LLC
Product code: FQH
Advisory panel: General Hospital
Date received: 2011-05-10
Decision date: 2011-12-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gaithersburg, MD, US

Adverse events under product code FQH

product code FQH

Injury: 170
Malfunction: 2,513
Other: 1
Total: 2,684

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.