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FDA 510(k)

easyEndo™ E-Lite Single Use Powered Endoscopic Staplers; easyEndo™ E-Lite Single Use Powered Endoscopic Staplers with Curved Tip; easyEndo™ E-Lite Single Use Cartridges

K番号: K254291 · 2026-09-25

申請者Ezisurg Medical Co., Ltd.
決定日2026-09-25
製品コードGDW
諮問委員会SU
決定Substantially Equivalent

医療機器の概要

easyEndo™ E-Lite Single Use Powered Endoscopic Staplers; easyEndo™ E-Lite Single Use Powered Endoscopic Staplers with Curved Tip; easyEndo™ E-Lite Single Use Cartridges is the device name listed in this FDA 510(k) record. The listed applicant is Ezisurg Medical Co., Ltd.. It received FDA 510(k) clearance on 2026-09-25 under 510(k) number K254291. The device is classified under product code GDW. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the easyEndo™ E-Lite Single Use Powered Endoscopic Staplers; easyEndo™ E-Lite Single Use Powered Endoscopic Staplers with Curved Tip; easyEndo™ E-Lite Single Use Cartridges?

easyEndo™ E-Lite Single Use Powered Endoscopic Staplers; easyEndo™ E-Lite Single Use Powered Endoscopic Staplers with Curved Tip; easyEndo™ E-Lite Single Use Cartridges is a medical device that received FDA 510(k) clearance on 2026-09-25. The listed applicant is Ezisurg Medical Co., Ltd.. The 510(k) number is K254291.

When did easyEndo™ E-Lite Single Use Powered Endoscopic Staplers; easyEndo™ E-Lite Single Use Powered Endoscopic Staplers with Curved Tip; easyEndo™ E-Lite Single Use Cartridges receive FDA 510(k) clearance?

easyEndo™ E-Lite Single Use Powered Endoscopic Staplers; easyEndo™ E-Lite Single Use Powered Endoscopic Staplers with Curved Tip; easyEndo™ E-Lite Single Use Cartridges received FDA 510(k) clearance on 2026-09-25, under 510(k) number K254291.

Who is the listed applicant for easyEndo™ E-Lite Single Use Powered Endoscopic Staplers; easyEndo™ E-Lite Single Use Powered Endoscopic Staplers with Curved Tip; easyEndo™ E-Lite Single Use Cartridges?

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

What is the FDA product code for easyEndo™ E-Lite Single Use Powered Endoscopic Staplers; easyEndo™ E-Lite Single Use Powered Endoscopic Staplers with Curved Tip; easyEndo™ E-Lite Single Use Cartridges?

The FDA product code for easyEndo™ E-Lite Single Use Powered Endoscopic Staplers; easyEndo™ E-Lite Single Use Powered Endoscopic Staplers with Curved Tip; easyEndo™ E-Lite Single Use Cartridges is GDW.

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

関連レコードは、名称、製品コード、その他のメタデータを使用して自動的にマッチングされます。マッチは検証された臨床的、科学的、企業的、または規制上の関係を確立するものではありません。リンクされた公式情報源をご確認ください。

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関連機器（コード：GDW）

関連レコードは、名称、製品コード、その他のメタデータを使用して自動的にマッチングされます。マッチは検証された臨床的、科学的、企業的、または規制上の関係を確立するものではありません。リンクされた公式情報源をご確認ください。

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