510(k) DEN180013
DEN180013 is an FDA 510(k) premarket notification submitted by Kci USA, Inc. for the device "PREVENA 125 and PREVENA PLUS 125 Therapy Units". The FDA issued a decision of De Novo Granted on April 19, 2019. The device falls under product code QFC (Negative Pressure Wound Therapy Device For Reduction Of Wound Complications), a Class II device regulated under 21 CFR 878.4783. Kci USA, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- April 19, 2019
- Date Received
- March 15, 2018
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Negative Pressure Wound Therapy Device For Reduction Of Wound Complications
- Device Class
- Class II
- Regulation Number
- 878.4783
- Review Panel
- SU
- Submission Type
A negative pressure wound therapy device for reduction of wound complications is a powered suction pump intended for wound management and reduction of wound complications via application of negative pressure to the wound, which removes fluids, including wound exudate, irrigation fluids, and infectious materials. This device type is intended for use with wound dressings classified under 21 CFR 878.4780. This classification does not include devices intended for organ space wounds.