Armis VeriCyn Wound Wash— 510(k) K220759

Name: FDA 510(k) clearance K220759
Creator: U.S. Food and Drug Administration
Published: 2023-05-25

Substantially Equivalent

Armis Biopharma, Inc.

FDA 510(k) clearance K220759 for Armis VeriCyn Wound Wash, Substantially Equivalent on 2023-05-25. Applicant: Armis Biopharma, Inc.. Device class: 2.

Clearance details

Applicant: Armis Biopharma, Inc.
Product code: Code FQH
Device class: Class 2
Regulation: 21 CFR 880.5475
Advisory panel: General Hospital
Date received: 2022-03-15
Decision date: 2023-05-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fort Collins, CO, US

Download summary PDF View on FDA.gov ↗

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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.