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
K203716 is the FDA 510(k) clearance record for 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, a class II device, cleared for Smith and Nephew Medical Limited on under FDA product code QFC (Negative Pressure Wound Therapy Device For Reduction Of Wound Complications). FDA's definition for product code QFC reads: "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...". FDA records list 32 510(k) clearances for Smith and Nephew Medical Limited, from to . As of , FDA records show no recalls naming K203716.
Clearance record
- Decision date
- Received
- (358 days to decision)
- Product code
- QFC Negative Pressure Wound Therapy Device For Reduction Of Wound Complications
- Regulation
- 21 CFR 878.4783
- Device class
- Class II
- Review panel
- General, Plastic Surgery
- Applicant
- Smith and Nephew Medical Limited 101 Hessle Rd., Hull, GB
- 510(k) summary
- Summary PDF
- Third party review
- No
Clearances, product code QFC
Trailing 12 monthsFDA records hold no clearances under product code QFC in the trailing twelve months.
Show the numbers
| Month | Clearances |
|---|---|
| November 2025 | 0 |
| December 2025 | 0 |
| January 2026 | 0 |
| February 2026 | 0 |
| March 2026 | 0 |
| April 2026 | 0 |
| May 2026 | 0 |
| June 2026 | 0 |
| July 2026 | 0 |
| August 2026 | 0 |
| September 2026 | 0 |
| October 2026 | 0 |
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