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. Device class: 2.
Clearance details
- Applicant
- Devon Medical Products
- 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
- King Of Prussia, PA, US
Recent devices under product code OMP
view allMore clearances from Devon Medical Products
view all- K161209 — Cirona 6400
- K151189 — Cirona 6300 Disposable Deep Vein Thrombosis (DVT) Prevention System
- K151240 — 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
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.