Renasys-F XL Foam Dressing Kit With Soft Port, Renasys XL Transparent Film Dressing— 510(k) K202783

Substantially Equivalent

Smith & Nephew Medical Limited

FDA 510(k) clearance K202783 for Renasys-F XL Foam Dressing Kit With Soft Port, Renasys XL Transparent Film Dressing, Substantially Equivalent on 2022-01-14. Applicant: Smith & Nephew Medical Limited.

Clearance details

Applicant: Smith & Nephew Medical Limited
Product code: Code OMP
Advisory panel: General, Plastic Surgery
Date received: 2020-09-22
Decision date: 2022-01-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hull, GB

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.