FDA 510(k)

GripTract-GI™內視鏡組織操作器上消化道模型 GT-GS100

K 號：K251041 · 2025-10-31

決定日期2025-10-31

產品代碼FDS

諮詢委員會GU

決定相當於

器材摘要

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.

常見問題

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.

其他以 Actuated Medical, Inc. 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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相關器械（代碼：FDS）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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官方來源

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