510(k) K223263
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.