FDA cleared the RENASYS ABDO SHIELD Temporary Abdominal Closure Kit (66807747) from Smith & Nephew Medical, Ltd. on Oct 23, 2026 under K261982, a traditional 510(k). The device falls under product code OMP, Negative Pressure Wound Therapy Powered Suction Pump, regulated at 21 CFR 878.4780 as a Class 2 device. The review panel was General, Plastic Surgery.
FDA logged the submission as received on Jun 12, 2026. The decision came 133 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.
Smith & Nephew Medical, Ltd. has 7 other decisions in the tracker over the last 12 months: K263348 (Q-FIX KNOTLESS All-Suture Anchor, 1.8mm, with one ULTRABRAID Suture, Blue; Q-FIX KNOTLESS All-Suture Anchor, 1.8mm, with one ULTRABRAID Suture, Cobraid Blue; Q-FIX KNOTLESS All-Suture Anchor, 1.8mm, with one MINITAPE Suture, Blue; Q-FIX KNOTLESS All-Suture Anchor, 1.8mm, with one MINITAPE Suture, Cobraid Blue; Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one Black knotless and one Blue MINITAPE Suture; Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one Blue knotless and one Black MINIT), K261338 (RENASYS DYNAFLOW Kit (66807741)), K261462 (LANDMARK Total Knee System), K261968 (Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one black knotless and one blue MINITAPE suture (72205981); Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one blue knotless and one black MINITAPE suture (72205982)).