Traus SSG10 手术系统
K号: K233153 · 2024-09-20
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决定日期2024-09-20
产品代码HBC
咨询委员会NE
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器械摘要
Traus SSG10 Surgical System is the device name listed in this FDA 510(k) record. The listed applicant is Saeshin Precision Co., Ltd.. It received FDA 510(k) clearance on 2024-09-20 under 510(k) number K233153. The device is classified under product code HBC. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Traus SSG10 Surgical System?
Traus SSG10 Surgical System is a medical device that received FDA 510(k) clearance on 2024-09-20. The listed applicant is Saeshin Precision Co., Ltd.. The 510(k) number is K233153.
When did Traus SSG10 Surgical System receive FDA 510(k) clearance?
Traus SSG10 Surgical System received FDA 510(k) clearance on 2024-09-20, under 510(k) number K233153.
Who is the listed applicant for Traus SSG10 Surgical System?
The FDA 510(k) record lists Saeshin Precision Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Traus SSG10 Surgical System?
The FDA product code for Traus SSG10 Surgical System is HBC.
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Saeshin Precision Co., Ltd.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：HBC）
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。
K254174手术动力系统Guizhou Zirui Technology Co., Ltd.K232938Traus SSG30 手术系统Saeshin Precision Co., Ltd.K213697ORiGO 系统Bien-Air Surgery SAK220485无线手控装置，EG1A（WIRELESS-HC），无线手控装置接收器，EG1A（RECEIVER-HC）The Anspach Effort, Inc.K193630hekaDrillZethon, Ltd.K183515MR8 钻孔系统，Midas Rex MR8 ClearView 工具Medtronic Powered Surgical Solutions
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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