RENASYS Foam Wound Dressing Kit with AIRLOCK Technology and Soft Port +1 more— 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 +1 more, Substantially Equivalent on 2025-02-18. Applicant: Smith & Nephew Medical, Ltd.. Device class: 2.
Clearance details
- Device name as filed
- RENASYS Foam Wound Dressing Kit with AIRLOCK Technology and Soft Port; RENASYS Gauze Wound Dressing Kit with AIRLOCK Technology and Soft Port
- Applicant
- Smith & Nephew Medical, Ltd.
- Product code
- Code OMP
- Device class
- Class 2
- Regulation
- 21 CFR 878.4780
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Hull, GB
Recent devices under product code OMP
view allMore clearances from Smith & Nephew Medical, Ltd.
view all- K251826 — RENASYS WOUND+ Dressing Kit with AIRLOCK Technology
- K231939 — Renasys Edge
- K190730 — IODOSORB
- K190756 — IODOFLEX
- K153209 — RENASYS TOUCH Negative Pressure Wound Therapy, RENASYS TOUCH Canisters, RENASYS TOUCH Carry Bag, Carry Strap, RENASYS Y-Connector, RENASYS TOUCH IV Pole/Bed Clamp, RENASYS TOUCH Class 2 Power Supply
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.