FDA 510(k)

LAGIS Endoscopic Instruments- Scissors (EI-330S EI-330S-T EI-330MS EI-330MS-T)

N.º K: K253134 · 2026-05-20

Fecha de decisión2026-05-20

Código de productoGEI

Comité asesorSU

DecisiónSubstantially Equivalent

Resumen del dispositivo

LAGIS Endoscopic Instruments- Scissors (EI-330S EI-330S-T EI-330MS EI-330MS-T) is the device name listed in this FDA 510(k) record. The listed applicant is Lagis Enterprise Co., Ltd.. It received FDA 510(k) clearance on 2026-05-20 under 510(k) number K253134. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the LAGIS Endoscopic Instruments- Scissors (EI-330S EI-330S-T EI-330MS EI-330MS-T)?

LAGIS Endoscopic Instruments- Scissors (EI-330S EI-330S-T EI-330MS EI-330MS-T) is a medical device that received FDA 510(k) clearance on 2026-05-20. The listed applicant is Lagis Enterprise Co., Ltd.. The 510(k) number is K253134.

When did LAGIS Endoscopic Instruments- Scissors (EI-330S EI-330S-T EI-330MS EI-330MS-T) receive FDA 510(k) clearance?

LAGIS Endoscopic Instruments- Scissors (EI-330S EI-330S-T EI-330MS EI-330MS-T) received FDA 510(k) clearance on 2026-05-20, under 510(k) number K253134.

Who is the listed applicant for LAGIS Endoscopic Instruments- Scissors (EI-330S EI-330S-T EI-330MS EI-330MS-T)?

The FDA 510(k) record lists Lagis Enterprise Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LAGIS Endoscopic Instruments- Scissors (EI-330S EI-330S-T EI-330MS EI-330MS-T)?

The FDA product code for LAGIS Endoscopic Instruments- Scissors (EI-330S EI-330S-T EI-330MS EI-330MS-T) is GEI.

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Otros registros que enlistan a Lagis Enterprise Co., Ltd. como solicitante

K243867LAGIS Suction Irrigation System K240334LAGIS Endoscopic Instruments - Grasper (DI-5670-33D, DI-5670-45D, DI-5716-33D, DI-5716-45D, DI-5719-33D, DI-5731-33D, DI-5731-45D, DI-5901-33D, DI-5901-45D)

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Fuente oficial

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