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FDA 510(k)

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

Número K: K252015 · 2026-01-28

RequerenteKoru Medical Systems, Inc.
Data da decisão2026-01-28
Código do produtoFRN
Comité consultivoHO
DecisãoSubstantially Equivalent

Resumo do dispositivo

FreedomEdge Infusion System; High-Flo SubQ Needle Set; Precision Flow Rate Tubing is the device name listed in this FDA 510(k) record. The listed applicant is Koru Medical Systems, Inc.. It received FDA 510(k) clearance on 2026-01-28 under 510(k) number K252015. The device is classified under product code FRN. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the FreedomEdge Infusion System; High-Flo SubQ Needle Set; Precision Flow Rate Tubing?

FreedomEdge Infusion System; High-Flo SubQ Needle Set; Precision Flow Rate Tubing is a medical device that received FDA 510(k) clearance on 2026-01-28. The listed applicant is Koru Medical Systems, Inc.. The 510(k) number is K252015.

When did FreedomEdge Infusion System; High-Flo SubQ Needle Set; Precision Flow Rate Tubing receive FDA 510(k) clearance?

FreedomEdge Infusion System; High-Flo SubQ Needle Set; Precision Flow Rate Tubing received FDA 510(k) clearance on 2026-01-28, under 510(k) number K252015.

Who is the listed applicant for FreedomEdge Infusion System; High-Flo SubQ Needle Set; Precision Flow Rate Tubing?

The FDA 510(k) record lists Koru Medical Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FreedomEdge Infusion System; High-Flo SubQ Needle Set; Precision Flow Rate Tubing?

The FDA product code for FreedomEdge Infusion System; High-Flo SubQ Needle Set; Precision Flow Rate Tubing is FRN.

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Fonte oficial

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