K234039

AEON Endoscopic Powered Stapler (Short/AEPH060); AEON Endoscopic Powered Stapler (Medium/AEPH160); AEON Endoscopic Powered Stapler (Long/AEPH260)

510(k) 号
K234039
器械名称
AEON Endoscopic Powered Stapler (Short/AEPH060); AEON Endoscopic Powered Stapler (Medium/AEPH160); AEON Endoscopic Powered Stapler (Long/AEPH260)
申请人
Lexington Medical, Inc. MA · US
产品代码
GAG — Stapler, Surgical
批准日期
2024-05-07
受理日期
2023-12-21
决定
Substantially Equivalent
审查途径
Traditional
咨询委员会
General Hospital
510(k) Summary(FDA 官方 PDF): K234039.pdf
FDA 官方记录: K234039
数据来自 openFDA 510(k) 数据集(CC0 公有领域),以 FDA 现行记录为准。510(k) 许可不等于 FDA 认证或批准。