WoundPro Negative Pressure Wound Therapy System— 510(k) K150960

Substantially Equivalent

Pensar Medical, LLC

FDA 510(k) clearance K150960 for WoundPro Negative Pressure Wound Therapy System, Substantially Equivalent on 2016-12-01. Applicant: Pensar Medical, LLC.

Clearance details

Applicant: Pensar Medical, LLC
Product code: Code OMP
Advisory panel: General, Plastic Surgery
Date received: 2015-04-10
Decision date: 2016-12-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Temecula, CA, US

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.