Invia Foam Dressing Kit Small, Invia Foam Dressing Kit Medium, Invia Foam Dressing Kit Large— 510(k) K151261

Substantially Equivalent

Medela AG

FDA 510(k) clearance K151261 for Invia Foam Dressing Kit Small, Invia Foam Dressing Kit Medium, Invia Foam Dressing Kit Large, Substantially Equivalent on 2015-10-07. Applicant: Medela AG.

Clearance details

Applicant: Medela AG
Product code: Code OMP
Advisory panel: General, Plastic Surgery
Date received: 2015-05-12
Decision date: 2015-10-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Baar Zug, CH

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.