FDA 510(k)

LAP-iX2N

Número K: K253165 · 2026-06-09

Data da decisão2026-06-09

Código do produtoGEI

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

LAP-iX2N is the device name listed in this FDA 510(k) record. The listed applicant is Sejong Medical Co., Ltd.. It received FDA 510(k) clearance on 2026-06-09 under 510(k) number K253165. 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 LAP-iX2N?

LAP-iX2N is a medical device that received FDA 510(k) clearance on 2026-06-09. The listed applicant is Sejong Medical Co., Ltd.. The 510(k) number is K253165.

When did LAP-iX2N receive FDA 510(k) clearance?

LAP-iX2N received FDA 510(k) clearance on 2026-06-09, under 510(k) number K253165.

Who is the listed applicant for LAP-iX2N?

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

What is the FDA product code for LAP-iX2N?

The FDA product code for LAP-iX2N is GEI.

Outros registros que listam Sejong Medical Co., Ltd. como candidato(a)

Registros relacionados são pareados automaticamente usando nomes, códigos de produtos ou outros metadados. Um pareamento não estabelece um vínculo clínico, científico, corporativo ou regulatório verificado; revise as fontes oficiais vinculadas.

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Fonte oficial

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