FDA cleared the Kii Structural Balloon Access System from Applied Medical Resources Corp. on Oct 31, 2025 under K252442, a traditional 510(k). The device falls under product code GCJ, Laparoscope, General & Plastic Surgery, regulated at 21 CFR 876.1500 as a Class 2 device. The review panel was Gastroenterology, Urology.
FDA logged the submission as received on Aug 4, 2025. The decision came 88 days later, inside the 90 FDA-day goal for a 510(k).
Applied Medical Resources Corp. has 5 other decisions in the tracker over the last 12 months: K260982 (Alexis lighted wound protector-retractor, flexible, extra small (cl312);Alexis lighted wound protector-retractor, flexible, small (cl301);Alexis lighted wound protector-retractor, flexible, medium (cl302);Alexis lighted wound protector-retractor, flexible, large (cl303);Alexis lighted wound protector-retractor, rigid, small (cl401);Alexis lighted wound protector-retractor, rigid, medium (cl402); Alexis lighted wound protector-retractor, rigid, large (cl403)), K253531 (Alexis® Lighted Wound Protector-Retractor, Rigid, Medium (CL402); Alexis® Lighted Wound Protector-Retractor, Flexible, Medium (CL302)), K252740 (Voyant® Open Fusion Device (EB240/Open Fusion)), K252412 (Voyant® Electrosurgical Generator (EA030/Electrosurgical Generator)).