510(k) K231918

Freedom60 Infusion Pump; High-Flo Subcutaneous Needle Sets; Precision Flow Rate Tubing; High-Flo Super26 Subcutaneous Needle Sets; Freedom60 Pre-Filled Syringe Adapter by Koru Medical Systems — Product Code FRN

K231918 is an FDA 510(k) premarket notification submitted by Koru Medical Systems for the device "Freedom60 Infusion Pump; High-Flo Subcutaneous Needle Sets; Precision Flow Rate Tubing; High-Flo Super26 Subcutaneous Needle Sets; Freedom60 Pre-Filled Syringe Adapter". The FDA issued a decision of Substantially Equivalent on November 3, 2023. The device falls under product code FRN (Pump, Infusion), a Class II device regulated under 21 CFR 880.5725. Koru Medical Systems has at least 1 other 510(k) clearance on record.