Prospera Spectruum Negative Pressure Wound Therapy Black Foam Kits and White Foam Accessory— 510(k) K250586
Substantially EquivalentDeroyal Industries, Inc.
FDA 510(k) clearance K250586 for Prospera Spectruum Negative Pressure Wound Therapy Black Foam Kits and White Foam Accessory, Substantially Equivalent on 2025-11-21. Applicant: Deroyal Industries, Inc.. Device class: 2.
Clearance details
- Applicant
- Deroyal Industries, 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
- Traditional
- Location
- Powell, TN, 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.