510(k) K223263
K223263 is an FDA 510(k) premarket notification submitted by 3M for the device "Prevena Plus 125 Therapy Unit". The FDA issued a decision of Substantially Equivalent on February 13, 2023. 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. 3M has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 13, 2023
- Date Received
- October 24, 2022
- Clearance Type
- Traditional
- 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.