WOUND PRO APEX
FDA 510(k) clearance K100823 · decided 2011-01-24
Clearance details
- K-number
- K100823
- Device name
- WOUND PRO APEX
- Applicant
- Accuro Medical Products, LLC
- Decision
- Substantially Equivalent
- Date received
- 2010-03-24
- Decision date
- 2011-01-24
- Days to decision
- 306 days
- Clearance type
- Traditional
- Product code
- OMP
- Device class
- 2
- Regulation number
- 878.4780
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Denver, CO, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Wound Pro Apex Negative Pressure Wound Therapy Powered Suction Pump; Accuro Medical Produc recall (Z-0009-2013) | Accuro Medical Product LLC | 2012-10-04 |