PICO Single Use Negative Pressure Wound Therapy System
K172521 is the FDA 510(k) clearance record for PICO Single Use Negative Pressure Wound Therapy System, a class II device, cleared for Smith & Nephew Medical Limited on under FDA product code OMP (Negative Pressure Wound Therapy Powered Suction Pump). FDA's definition for product code OMP reads: "For wound management via application of continual or intermittent negative pressure to the wound for removal of fluids, including wound exudate, irrigation fluids, and infectious materials. The Device is indicated for management of...". FDA records list 32 510(k) clearances for Smith & Nephew Medical Limited, from to . As of , FDA records show no recalls naming K172521.
Clearance record
- Decision date
- Received
- (30 days to decision)
- Product code
- OMP Negative Pressure Wound Therapy Powered Suction Pump
- Regulation
- 21 CFR 878.4780
- Device class
- Class II
- Review panel
- General, Plastic Surgery
- Applicant
- Smith & Nephew Medical Limited 101 Hessle Rd., Hull, GB
- 510(k) summary
- Summary PDF
- Third party review
- No
Clearances, product code OMP
Trailing 12 monthsShow the numbers
| Month | Clearances |
|---|---|
| November 2025 | 1 |
| December 2025 | 0 |
| January 2026 | 0 |
| February 2026 | 0 |
| March 2026 | 1 |
| April 2026 | 0 |
| May 2026 | 3 |
| June 2026 | 2 |
| July 2026 | 0 |
| August 2026 | 0 |
| September 2026 | 1 |
| October 2026 | 0 |
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.
