FDA 510(k)

Manual Tissue Removal Device

N.º K: K254050 · 2026-05-15

SolicitanteSuzhou AcuVu Medical Technology Co., Ltd.

Fecha de decisión2026-05-15

Código de productoHIH

Comité asesorOB

DecisiónSubstantially Equivalent

Resumen del dispositivo

Manual Tissue Removal Device is the device name listed in this FDA 510(k) record. The listed applicant is Suzhou AcuVu Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2026-05-15 under 510(k) number K254050. The device is classified under product code HIH. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Manual Tissue Removal Device?

Manual Tissue Removal Device is a medical device that received FDA 510(k) clearance on 2026-05-15. The listed applicant is Suzhou AcuVu Medical Technology Co., Ltd.. The 510(k) number is K254050.

When did Manual Tissue Removal Device receive FDA 510(k) clearance?

Manual Tissue Removal Device received FDA 510(k) clearance on 2026-05-15, under 510(k) number K254050.

Who is the listed applicant for Manual Tissue Removal Device?

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

What is the FDA product code for Manual Tissue Removal Device?

The FDA product code for Manual Tissue Removal Device is HIH.

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Fuente oficial

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