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510(k) clearances

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. · General, Plastic Surgery

K254291Substantially EquivalentTraditionalGDW
Open FDA's page for this record
Third party flag
N
City
Shanghai
Advisory committee description
General, Plastic Surgery
Address 1
# 399, Miaoqiao Rd., Pudong New District
Statement or summary
Summary
Product code
GDW
Zip code
201315
Applicant
Ezisurg Medical Co., Ltd.
Decision date
2026-09-25
Decision code
SESE
Country code
CN
Advisory committee
SU
Contact
Hong Zhu
K number
K254291
Date received
2025-12-31
Review advisory committee
SU
Postal code
201315
Decision description
Substantially Equivalent
Clearance type
Traditional
Device name

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

Harmonized identifiers (openFDA)
Device name
Staple, Implantable
Medical specialty description
General, Plastic Surgery
Regulation number
878.4750
Device class
2
Registration number
3010326740, 3017196117, 3011063460, 3017102971, 3024021261, 1018470, 3003898360, 3007205024, 3016678045, 3017636737, 3004812220, 3007487007, 3009380063, 3010432890, 1213643, 2011171, 3015183635, 3030733800, 2183469, 3011301103, 3015612252, 2244012, 1219602, 3009161688, 3008383115, 3007093114, 2020394, 3010913847, 1054241, 3004447686, 9710649, 1047423, 1018233, 3011050570, 3010041511, 3020331900, 3006451981, 1064858, 3010885402, 3022626486 +118 more
FEI number
3010326740, 3017196117, 3011063460, 3017102971, 3024021261, 1000138054, 1000219637, 1018470, 3003898360, 3007205024, 3016678045, 3017636737, 3004812220, 3002993297, 3007487007, 3009380063, 3010432890, 1213643, 2011171, 3015183635, 3030733800, 2183469, 3011301103, 3015612252, 2244012, 3002807095, 1219602, 3009161688, 3008383115, 3007093114, 2020394, 3010913847, 3004447686, 1018233, 3011050570, 3010041511, 3020331900, 3006451981, 3008615487, 3010885402 +118 more
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.