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-Nummer: K254291 · 2026-09-25

Entscheidungsdatum2026-09-25

ProduktcodeGDW

BeratungsausschussSU

EntscheidungSubstantially Equivalent

Produktübersicht

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.

Häufig gestellte Fragen

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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Verwandte Geräte (Code: GDW)

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