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
- 510(k) number
- K254291
- Applicant
- Ezisurg Medical Co., Ltd.
- Decision date
- Sep 25, 2026
- Date received
- Dec 31, 2025
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- GDW
- Device type
- Staple, Implantable
- Device class
- Class II
- Regulation
- 21 CFR 878.4750
- Advisory committee
- General, Plastic Surgery
- Statement or summary
- Summary
- Third party
- N
- Location
- Shanghai, CN