RENASYS Foam Wound Dressing Kit with AIRLOCK Technology and Soft Port; RENASYS Gauze Wound Dressing Kit with AIRLOCK Technology and Soft Port— 510(k) K243576
Substantially EquivalentSmith & Nephew Medical, Ltd.
FDA 510(k) clearance K243576 for RENASYS Foam Wound Dressing Kit with AIRLOCK Technology and Soft Port; RENASYS Gauze Wound Dressing Kit with AIRLOCK Technology and Soft Port, Substantially Equivalent on 2025-02-18. Applicant: Smith & Nephew Medical, Ltd..
Clearance details
- Applicant
- Smith & Nephew Medical, Ltd.
- Product code
- Code OMP
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Hull, GB
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, through . 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.