RENASYS¿ EZ PLUS Negative Pressure Wound Therapy Device— 510(k) K151326
Substantially EquivalentSmith & Nephew, Inc.
FDA 510(k) clearance K151326 for RENASYS¿ EZ PLUS Negative Pressure Wound Therapy Device, Substantially Equivalent on 2015-07-16. Applicant: Smith & Nephew, Inc.. Device class: 2.
Clearance details
- Applicant
- Smith & Nephew, Inc.
- 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
- Special
- Location
- St Petersburg, FL, US
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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.