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easyEndo™ E-Lite Single Use Powered Endoscopic Staplers

by Ezisurg Medical Co., Ltd. 510(k)

Active United States

510(k) K254291

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK254291 Date25 Sep 2026ClearedStatusActive

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 26 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
GDW
Device Class
Class II
Regulation
21 CFR Part 878.4750
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

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