RENASYS WOUND+ Dressing Kit with AIRLOCK Technology— 510(k) K251826

Substantially Equivalent

Smith & Nephew Medical, Ltd.

FDA 510(k) clearance K251826 for RENASYS WOUND+ Dressing Kit with AIRLOCK Technology, Substantially Equivalent on 2025-09-11. Applicant: Smith & Nephew Medical, Ltd..

Clearance details

Applicant: Smith & Nephew Medical, Ltd.
Product code: Code OMP
Advisory panel: General, Plastic Surgery
Date received: 2025-06-13
Decision date: 2025-09-11
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.