510(k) K254291
K254291 is an FDA 510(k) premarket notification submitted by Ezisurg Medical Co., Ltd. for the device "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 issued a decision of Substantially Equivalent on Sep 25, 2026. The device falls under product code GDW (Staple, Implantable), a Class II device regulated under 21 CFR 878.4750. Ezisurg Medical Co., Ltd. has 5 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Sep 25, 2026
- Date Received
- Dec 31, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Staple, Implantable
- Device Class
- Class II
- Regulation Number
- 878.4750
- Review Panel
- SU
- Submission Type
- 510(k)