FreedomEdge Infusion System; High-Flo SubQ Needle Set; Precision Flow Rate Tubing
Jan 2026
215d
Koru Medical Systems, Inc.
1
Total
1
Cleared
0
Denied
Koru Medical Systems, Inc. — FDA 510(k) Submissions
Koru Medical Systems, Inc. has submitted 1 FDA 510(k) premarket notifications since 2026, of which 1 received clearance as substantially equivalent to a predicate device.
The company's most frequent device categories include Pump, Infusion . Use the specialty filter in the sidebar to narrow results.
1 devices