510(k) K190539

TurnSignal Stopcocks Sterile, TurnSignal Stopcocks Buld Non Sterile, TurnSignal Stopcocks with Manifolds Sterile, TurnSignal Stopcocks with Manifolds Bulk Non Sterile by Monumedical, LLC — Product Code FMG

K190539 is an FDA 510(k) premarket notification submitted by Monumedical, LLC for the device "TurnSignal Stopcocks Sterile, TurnSignal Stopcocks Buld Non Sterile, TurnSignal Stopcocks with Manifolds Sterile, TurnSignal Stopcocks with Manifolds Bulk Non Sterile". The FDA issued a decision of Substantially Equivalent on October 22, 2019. The device falls under product code FMG (Stopcock, I.V. Set), a Class II device regulated under 21 CFR 880.5440.