GripTract-GI 内窥镜组织操纵器
K号: K231254 · 2023-11-03
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决定日期2023-11-03
产品代码FDF
咨询委员会GU
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决定实质等同
器械摘要
GripTract-GI Endoscopic Tissue Manipulator is the device name listed in this FDA 510(k) record. The listed applicant is Actuated Medical, Inc.. It received FDA 510(k) clearance on 2023-11-03 under 510(k) number K231254. The device is classified under product code FDF. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the GripTract-GI Endoscopic Tissue Manipulator?
GripTract-GI Endoscopic Tissue Manipulator is a medical device that received FDA 510(k) clearance on 2023-11-03. The listed applicant is Actuated Medical, Inc.. The 510(k) number is K231254.
When did GripTract-GI Endoscopic Tissue Manipulator receive FDA 510(k) clearance?
GripTract-GI Endoscopic Tissue Manipulator received FDA 510(k) clearance on 2023-11-03, under 510(k) number K231254.
Who is the listed applicant for GripTract-GI Endoscopic Tissue Manipulator?
The FDA 510(k) record lists Actuated Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for GripTract-GI Endoscopic Tissue Manipulator?
The FDA product code for GripTract-GI Endoscopic Tissue Manipulator is FDF.
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Actuated Medical, Inc.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：FDF）
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。
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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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