510(k) K211680

Streamline Surgical System by New World Medical, Inc. — Product Code MRH

K211680 is an FDA 510(k) premarket notification submitted by New World Medical, Inc. for the device "Streamline Surgical System". The FDA issued a decision of Substantially Equivalent on October 8, 2021. The device falls under product code MRH (Pump, Infusion, Ophthalmic), a Class II device regulated under 21 CFR 880.5725. New World Medical, Inc. has at least 10 other 510(k) clearances on record.