extriCARE 3600 Negative Pressure Wound Therapy System 1000cc canister— 510(k) K143362
Substantially EquivalentDevon Medical Products
FDA 510(k) clearance K143362 for extriCARE 3600 Negative Pressure Wound Therapy System 1000cc canister, Substantially Equivalent on 2015-02-03. 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.