FDA 510(k)

握道-GI內視鏡組織操作器

K 號：K231254 · 2023-11-03

決定日期2023-11-03

產品代碼FDF

諮詢委員會GU

決定相當於

器材摘要

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.

常見問題

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.

其他以 Actuated Medical, Inc. 為申請人之記錄

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相關器械（代碼：FDF）

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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