510(k) K203716
K203716 is an FDA 510(k) premarket notification submitted by Smith and Nephew Medical Limited for the device "PICO Single Use Negative Pressure Wound Therapy System, PICO 7 Single Use Negative Pressure Wound Therapy System, PICO 7Y Single Use Negative Pressure Wound Therapy System, PICO 14 Single Use Negative Pressure Wound Therapy System". The FDA issued a decision of Substantially Equivalent on December 14, 2021. 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. Smith and Nephew Medical Limited has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 14, 2021
- Date Received
- December 21, 2020
- 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.