TurnSignal Stopcocks Sterile, TurnSignal Stopcocks Buld Non Sterile, TurnSignal Stopcocks with Manifolds Sterile, TurnSignal Stopcocks with Manifolds Bulk Non Sterile

About This 510(k) Submission

K190539 is an FDA 510(k) clearance for the TurnSignal Stopcocks Sterile, TurnSignal Stopcocks Buld Non Sterile, TurnSignal Stopcocks with Manifolds Sterile, TurnSignal Stopcocks with Manifolds Bulk Non Sterile, a Stopcock, I.v. Set (Class II — Special Controls, product code FMG), submitted by Monumedical, LLC (Roseville, US). The FDA issued a Cleared decision on October 22, 2019, 232 days after receiving the submission on March 4, 2019. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5440.