FDA 510(k)

NORMOFLO™ Irrigation Fluid Warming Sets and Accessories (IR-601, IR-501, IR-61, PL-61)

N.º K: K262532 · 2026-09-18

Fecha de decisión2026-09-18

Código de productoLGZ

Comité asesorHO

DecisiónSubstantially Equivalent

Resumen del dispositivo

NORMOFLO™ Irrigation Fluid Warming Sets and Accessories (IR-601, IR-501, IR-61, PL-61) is the device name listed in this FDA 510(k) record. The listed applicant is ICU Medical. It received FDA 510(k) clearance on 2026-09-18 under 510(k) number K262532. The device is classified under product code LGZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the NORMOFLO™ Irrigation Fluid Warming Sets and Accessories (IR-601, IR-501, IR-61, PL-61)?

NORMOFLO™ Irrigation Fluid Warming Sets and Accessories (IR-601, IR-501, IR-61, PL-61) is a medical device that received FDA 510(k) clearance on 2026-09-18. The listed applicant is ICU Medical. The 510(k) number is K262532.

When did NORMOFLO™ Irrigation Fluid Warming Sets and Accessories (IR-601, IR-501, IR-61, PL-61) receive FDA 510(k) clearance?

NORMOFLO™ Irrigation Fluid Warming Sets and Accessories (IR-601, IR-501, IR-61, PL-61) received FDA 510(k) clearance on 2026-09-18, under 510(k) number K262532.

Who is the listed applicant for NORMOFLO™ Irrigation Fluid Warming Sets and Accessories (IR-601, IR-501, IR-61, PL-61)?

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

What is the FDA product code for NORMOFLO™ Irrigation Fluid Warming Sets and Accessories (IR-601, IR-501, IR-61, PL-61)?

The FDA product code for NORMOFLO™ Irrigation Fluid Warming Sets and Accessories (IR-601, IR-501, IR-61, PL-61) is LGZ.

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Fuente oficial

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