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FDA makes the Draeger VentStar Resus Neo hose removal a Class I recall Control Bionics wins a Class I CE mark for the NeuroStrip muscle sensor Medicare starts paying for Carlsmed Aprevo lumbar fusion under three new codes ABK Biomedical breaks ground on a Missouri plant for its Y90 microspheres Boston Scientific releases the last $8M from Elutia's BioEnvelope sale BlueWind gets a Category I CPT code for subfascial tibial neuromodulation Emboline runs its first US commercial Emboliner cases at Columbia SedMed raises $4M for a toilet lift that runs without power CDRH plans 11 final guidances in FY2027 and puts AI lifecycle management first FDA makes the Draeger VentStar Resus Neo hose removal a Class I recall Control Bionics wins a Class I CE mark for the NeuroStrip muscle sensor Medicare starts paying for Carlsmed Aprevo lumbar fusion under three new codes ABK Biomedical breaks ground on a Missouri plant for its Y90 microspheres Boston Scientific releases the last $8M from Elutia's BioEnvelope sale BlueWind gets a Category I CPT code for subfascial tibial neuromodulation Emboline runs its first US commercial Emboliner cases at Columbia SedMed raises $4M for a toilet lift that runs without power CDRH plans 11 final guidances in FY2027 and puts AI lifecycle management first

The Tracker / September 2026 / K254291

510(k) cleared

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

Ezisurg Medical Co., Ltd. · Sep 25, 2026 · K254291

FDA cleared 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 from Ezisurg Medical Co., Ltd. on Sep 25, 2026 under K254291, a traditional 510(k). The device falls under product code GDW, Staple, Implantable, regulated at 21 CFR 878.4750 as a Class 2 device. The review panel was General, Plastic Surgery.

FDA logged the submission as received on Dec 31, 2025. The decision came 268 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Ezisurg Medical Co., Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K254291?

K254291 is the FDA 510(k) 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, submitted by Ezisurg Medical Co., Ltd.. FDA's decision date was Sep 25, 2026, under product code GDW (Staple, Implantable).

Who makes 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?

Ezisurg Medical Co., Ltd., based in Shanghai, is the applicant of record for K254291.

How long did the K254291 review take?

FDA received the submission on Dec 31, 2025 and issued its decision on Sep 25, 2026, 268 days later.

← All decisions in September 2026