PROSPERA PRO-I, PRO-II AND PRO-III NEGATIVE PRESSURE WOUND THERAPY SYSTEM— 510(k) K112458
Substantially EquivalentMedica-Rents Co., Ltd.
FDA 510(k) clearance K112458 for PROSPERA PRO-I, PRO-II AND PRO-III NEGATIVE PRESSURE WOUND THERAPY SYSTEM, Substantially Equivalent on 2012-01-05. Applicant: Medica-Rents Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Medica-Rents Co., 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
- Special
- Location
- Derby, CT, US
Recent devices under product code OMP
view allAdverse 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.