PREVENA PLUS Incision Management System (No Ag); PREVENA PLUS DUO Incision Management System (No Ag)— 510(k) K190697

Substantially Equivalent

Kci USA, Inc.

FDA 510(k) clearance K190697 for PREVENA PLUS Incision Management System (No Ag); PREVENA PLUS DUO Incision Management System (No Ag), Substantially Equivalent on 2019-11-22. Applicant: Kci USA, Inc..

Clearance details

Applicant: Kci USA, Inc.
Product code: Code OMP
Advisory panel: General, Plastic Surgery
Date received: 2019-03-18
Decision date: 2019-11-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Antonio, TX, 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.