KEVO NPWT-AHEMO30 AND A HEMO45 FOAM DRESSING KIT— 510(k) K113199

Name: FDA 510(k) clearance K113199
Creator: U.S. Food and Drug Administration
Published: 2012-07-30

Substantially Equivalent

Kevo Medical Supplies

FDA 510(k) clearance K113199 for KEVO NPWT-AHEMO30 AND A HEMO45 FOAM DRESSING KIT, Substantially Equivalent on 2012-07-30. Applicant: Kevo Medical Supplies. Device class: 2.

Clearance details

Applicant: Kevo Medical Supplies
Product code: Code OMP
Device class: Class 2
Regulation: 21 CFR 878.4780
Advisory panel: General, Plastic Surgery
Date received: 2011-10-31
Decision date: 2012-07-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Crofton, MD, US

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Adverse events under product code OMP

product code OMP

Death: 31
Injury: 1,707
Malfunction: 4,047
Other: 1
Total: 5,786

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.