Class Class II

FreedomEdge Infusion System; High-Flo SubQ Needle Set; Precision Flow Rate Tubing (K252015)

K252015 2026-01-28 Traditional
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Description

FreedomEdge Infusion System; High-Flo SubQ Needle Set; Precision Flow Rate Tubing by Koru Medical Systems, Inc., an FDA 510(k) cleared general hospital device.

Regulatory Information

Device ClassClass Class II
510(k) NumberK252015
Clearance Date2026-01-28
Clearance TypeTraditional
Product CodeFRN
Regulation Number880.5725

Categories

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