FDA 510(k)

GripTract-GI™ 内窥镜组织操纵器上消化道模型 GT-GS100

K号: K251041 · 2025-10-31

决定日期2025-10-31

产品代码FDS

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决定实质等同

器械摘要

GripTract-GI™ Endoscopic Tissue Manipulator Upper GI Model GT-GS100 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 2025-10-31 under 510(k) number K251041. The device is classified under product code FDS. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the GripTract-GI™ Endoscopic Tissue Manipulator Upper GI Model GT-GS100?

GripTract-GI™ Endoscopic Tissue Manipulator Upper GI Model GT-GS100 is a medical device that received FDA 510(k) clearance on 2025-10-31. The listed applicant is Actuated Medical, Inc.. The 510(k) number is K251041.

When did GripTract-GI™ Endoscopic Tissue Manipulator Upper GI Model GT-GS100 receive FDA 510(k) clearance?

GripTract-GI™ Endoscopic Tissue Manipulator Upper GI Model GT-GS100 received FDA 510(k) clearance on 2025-10-31, under 510(k) number K251041.

Who is the listed applicant for GripTract-GI™ Endoscopic Tissue Manipulator Upper GI Model GT-GS100?

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 Upper GI Model GT-GS100?

The FDA product code for GripTract-GI™ Endoscopic Tissue Manipulator Upper GI Model GT-GS100 is FDS.

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。

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官方来源

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