FDA 510(k)

Hemolase Fiber (Hemo-R-0.40-2.5/Hemo-R-0.60-2.5/Hemo-R-0.40-1.8/Hemo-R-0.60-1.8)

N.º K: K261701 · 2026-06-18

SolicitanteMicro-Energy Medical Technology Co., Ltd.

Fecha de decisión2026-06-18

Código de productoGEX

Comité asesorSU

DecisiónSubstantially Equivalent

Resumen del dispositivo

Hemolase Fiber (Hemo-R-0.40-2.5/Hemo-R-0.60-2.5/Hemo-R-0.40-1.8/Hemo-R-0.60-1.8) is the device name listed in this FDA 510(k) record. The listed applicant is Micro-Energy Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2026-06-18 under 510(k) number K261701. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Hemolase Fiber (Hemo-R-0.40-2.5/Hemo-R-0.60-2.5/Hemo-R-0.40-1.8/Hemo-R-0.60-1.8)?

Hemolase Fiber (Hemo-R-0.40-2.5/Hemo-R-0.60-2.5/Hemo-R-0.40-1.8/Hemo-R-0.60-1.8) is a medical device that received FDA 510(k) clearance on 2026-06-18. The listed applicant is Micro-Energy Medical Technology Co., Ltd.. The 510(k) number is K261701.

When did Hemolase Fiber (Hemo-R-0.40-2.5/Hemo-R-0.60-2.5/Hemo-R-0.40-1.8/Hemo-R-0.60-1.8) receive FDA 510(k) clearance?

Hemolase Fiber (Hemo-R-0.40-2.5/Hemo-R-0.60-2.5/Hemo-R-0.40-1.8/Hemo-R-0.60-1.8) received FDA 510(k) clearance on 2026-06-18, under 510(k) number K261701.

Who is the listed applicant for Hemolase Fiber (Hemo-R-0.40-2.5/Hemo-R-0.60-2.5/Hemo-R-0.40-1.8/Hemo-R-0.60-1.8)?

The FDA 510(k) record lists Micro-Energy Medical Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Hemolase Fiber (Hemo-R-0.40-2.5/Hemo-R-0.60-2.5/Hemo-R-0.40-1.8/Hemo-R-0.60-1.8)?

The FDA product code for Hemolase Fiber (Hemo-R-0.40-2.5/Hemo-R-0.60-2.5/Hemo-R-0.40-1.8/Hemo-R-0.60-1.8) is GEX. This falls under the Gastroenterology category.

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Fuente oficial

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