Avance Solo Negative Pressure Wound Therapy (NPWT) System— 510(k) K203369
Substantially EquivalentMolnlycke Health Care Us, LLC
FDA 510(k) clearance K203369 for Avance Solo Negative Pressure Wound Therapy (NPWT) System, Substantially Equivalent on 2021-07-01. Applicant: Molnlycke Health Care Us, LLC. Device class: 2.
Clearance details
- Applicant
- Molnlycke Health Care Us, LLC
- 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
- Peachtree Corners, GA, 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.