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Koru Medical Systems
FDA Regulatory Profile
Summary
Total Recalls
0
510(k) Clearances
2
Inspections
0
Compliance Actions
0
Recent 510(k) Clearances
K-Number
Device
Date
K252015
FreedomEdge Infusion System; High-Flo SubQ Needle Set; Precision Flow Rate Tubing
January 28, 2026
K231918
Freedom60 Infusion Pump; High-Flo Subcutaneous Needle Sets; Precision Flow Rate Tubing; High-Flo Sup
November 3, 2023