Device type
Negative Pressure Wound Therapy Powered Suction Pump
Product code OMP · Class II · 21 CFR 878.4780 · General, Plastic Surgery
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 chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), flaps and grafts.
Recent 510(k)s
Oct 30, 2026
K260306
RENASYS-G 15Fr Channel Drain Gauze Dressing Kit (66802257); RENASYS 15Fr Channel Drain Accessory Kit (66802253)
Smith & Nephew Medical, Ltd.
- OMP
- Class II
Oct 23, 2026
K261982
RENASYS ABDO SHIELD Temporary Abdominal Closure Kit (66807747)
Smith & Nephew Medical, Ltd.
- OMP
- Class II
Oct 8, 2026
K260426
MeCare Alpha (MCA2019)
IVT Medical, Ltd.
- OMP
- Class II
Sep 11, 2026
K261338
RENASYS DYNAFLOW Kit (66807741)
Smith & Nephew Medical, Ltd.
- OMP
- Class II
Recent recalls
No recalls in the archive for OMP.