8Q10 Surclear烟雾羽流疏散系统
K号: K233789 · 2024-04-10
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决定日期2024-04-10
产品代码FYD
咨询委员会SU
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决定实质等同
器械摘要
8Q10 Surclear Smoke Plume Evacuation System is the device name listed in this FDA 510(k) record. The listed applicant is Surnic Corporation. It received FDA 510(k) clearance on 2024-04-10 under 510(k) number K233789. The device is classified under product code FYD. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the 8Q10 Surclear Smoke Plume Evacuation System?
8Q10 Surclear Smoke Plume Evacuation System is a medical device that received FDA 510(k) clearance on 2024-04-10. The listed applicant is Surnic Corporation. The 510(k) number is K233789.
When did 8Q10 Surclear Smoke Plume Evacuation System receive FDA 510(k) clearance?
8Q10 Surclear Smoke Plume Evacuation System received FDA 510(k) clearance on 2024-04-10, under 510(k) number K233789.
Who is the listed applicant for 8Q10 Surclear Smoke Plume Evacuation System?
The FDA 510(k) record lists Surnic Corporation as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for 8Q10 Surclear Smoke Plume Evacuation System?
The FDA product code for 8Q10 Surclear Smoke Plume Evacuation System is FYD.
相关临床试验
关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。
列明Surnic Corporation为申报人的其他记录
关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。
相关器械（代码：FYD）
关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。
K240127PlumeSafe X5 烟雾管理系统Conmed CorporationK213068Medline 烟雾抽吸罩Medline Industries, Inc.K202944NEBULAE SRS腹腔镜手术烟雾清除系统Northgate Technologies, Inc.K200250Megadyne烟雾抽吸器，Megadyne过滤器，Megadyne液体陷阱，Megadyne连接电缆，1米和2.1米，Megadyne射频传感器Megadyne Medical Products, Inc.K192035EvaQMax烟雾排放系统Bio Protech, Inc.K191328Megadyne足开关Megadyne Medical Products, Inc.
官方来源
在 FDA 数据库中查看 →数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。
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