FDA 510(k)

LAGIS内視鏡器具-カミソリ（EI-330S EI-330S-T EI-330MS EI-330MS-T）

K番号: K253134 · 2026-05-20

決定日2026-05-20

製品コードGEI

諮問委員会SU （以下のテキストは翻訳されていません。） Policy: medical-regulatory-v1

決定大幅同等

医療機器の概要

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.

よくある質問

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.

申請者としてLagis Enterprise Co., Ltd.を記載するその他の記録

K243867LAGIS吸引洗浄システム K240334LAGIS内視鏡器具 - グラスパー（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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