extriCARE 1000 Negative Pressure Wound Therapy System— 510(k) K213906

Substantially Equivalent

Alleva Medical, Ltd.

FDA 510(k) clearance K213906 for extriCARE 1000 Negative Pressure Wound Therapy System, Substantially Equivalent on 2023-03-08. Applicant: Alleva Medical, Ltd..

Clearance details

Applicant: Alleva Medical, Ltd.
Product code: Code OMP
Advisory panel: General, Plastic Surgery
Date received: 2021-12-14
Decision date: 2023-03-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shek Mun, HK

Download summary PDF View on FDA.gov ↗

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.