FDA 510(k)

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

Número K: K253134 · 2026-05-20

Data da decisão2026-05-20

Código do produtoGEI

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do 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.

Perguntas frequentes

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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Outros registros que listam Lagis Enterprise Co., Ltd. como candidato(a)

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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