K233318

AXIOS Stent and Electrocautery-Enhanced Delivery System (6mmx8mm); AXIOS Stent and Electrocautery-Enhanced Delivery System (8mmx8mm); AXIOS Stent and Electrocautery-Enhanced Delivery System (10mmx10mm); AXIOS Stent and Electrocautery-Enhanced Delivery System (15mmx10mm); AXIOS Stent and Electrocautery-Enhanced Delivery System (20mmx10mm); AXIOS Stent and Electrocautery-Enhanced Delivery System (15mmx15mm)

510(k) 号: K233318
器械名称: AXIOS Stent and Electrocautery-Enhanced Delivery System (6mmx8mm); AXIOS Stent and Electrocautery-Enhanced Delivery System (8mmx8mm); AXIOS Stent and Electrocautery-Enhanced Delivery System (10mmx10mm); AXIOS Stent and Electrocautery-Enhanced Delivery System (15mmx10mm); AXIOS Stent and Electrocautery-Enhanced Delivery System (20mmx10mm); AXIOS Stent and Electrocautery-Enhanced Delivery System (15mmx15mm)
申请人: Boston Scientific Corporation MA · US
产品代码: KNS — Unit, Electrosurgical, Endoscopic (With Or Without A
批准日期: 2023-10-27
受理日期: 2023-09-29
决定: Substantially Equivalent
审查途径: Special
咨询委员会: Gastroenterology, Urology

PDF下载 510(k) Summary本站存档 · 1.4 MB · FDA 公有领域文件

也可从 FDA 官方下载： K233318.pdf

FDA 官方记录： K233318

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。