FloSure Ventilation Patch— 510(k) K150459

Substantially Equivalent

Simex Medizintechnik GmbH

FDA 510(k) clearance K150459 for FloSure Ventilation Patch, Substantially Equivalent on 2016-01-05. Applicant: Simex Medizintechnik GmbH.

Clearance details

Applicant: Simex Medizintechnik GmbH
Product code: Code OMP
Advisory panel: General, Plastic Surgery
Date received: 2015-02-23
Decision date: 2016-01-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Deisslingen, DE

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.