extriCARE Negative Pressure Wound Therapy Gel Strip - 8pc, extriCARE Negative Pressure Wound Therapy Gel Strip - 7pc, extriCARE Negative Pressure Wound Therapy Gel Strip - 6pc, extriCARE Negative Pressure Wound Therapy Gel Strip - 5pc, extriCARE Negative Pressure Wound Therapy Gel Strip - 4pc— 510(k) K151240
Substantially EquivalentDevon Medical Products
FDA 510(k) clearance K151240 for extriCARE Negative Pressure Wound Therapy Gel Strip - 8pc, extriCARE Negative Pressure Wound Therapy Gel Strip - 7pc, extriCARE Negative Pressure Wound Therapy Gel Strip - 6pc, extriCARE Negative Pressure Wound Therapy Gel Strip - 5pc, extriCARE Negative Pressure Wound Therapy Gel Strip - 4pc, Substantially Equivalent on 2015-06-09. Applicant: Devon Medical Products.
Clearance details
- Applicant
- Devon Medical Products
- Product code
- Code OMP
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- King Of Prussia, PA, US
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.