120V Neptune S Rover (0711-001-000);V2 4-Port Manifold (0750-400-000);V2 Specimen Collection Manifold Kit (0750-200-000);V2 Specimen Collection Tray (0750-210-000)

About This 510(k) Submission

K222552 is an FDA 510(k) clearance for the 120V Neptune S Rover (0711-001-000);V2 4-Port Manifold (0750-400-000);V2 Specimen Collection Manifold Kit (0750-200-000);V2 Specimen Collection Tray (0750-210-000), a Apparatus, Suction, Ward Use, Portable, Ac-powered (Class II — Special Controls, product code JCX), submitted by Stryker Instruments (Kalamazoo, US). The FDA issued a Cleared decision on December 9, 2022, 108 days after receiving the submission on August 23, 2022. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4780.