FDA 510(k)

DiLumen C1、EZ1及工具固定座

K 號：K221452 · 2023-02-10

決定日期2023-02-10

產品代碼FDF

諮詢委員會GU

決定相當於

器材摘要

DiLumen C1, EZ1 and Tool Mount is the device name listed in this FDA 510(k) record. The listed applicant is Lumendi, LLC. It received FDA 510(k) clearance on 2023-02-10 under 510(k) number K221452. 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 DiLumen C1, EZ1 and Tool Mount?

DiLumen C1, EZ1 and Tool Mount is a medical device that received FDA 510(k) clearance on 2023-02-10. The listed applicant is Lumendi, LLC. The 510(k) number is K221452.

When did DiLumen C1, EZ1 and Tool Mount receive FDA 510(k) clearance?

DiLumen C1, EZ1 and Tool Mount received FDA 510(k) clearance on 2023-02-10, under 510(k) number K221452.

Who is the listed applicant for DiLumen C1, EZ1 and Tool Mount?

The FDA 510(k) record lists Lumendi, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DiLumen C1, EZ1 and Tool Mount?

The FDA product code for DiLumen C1, EZ1 and Tool Mount is FDF.

其他以 Lumendi, LLC 為申請人之記錄

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K211819DiLumen C2 及工具固定座 K210851DiLumen 腔內介入性平台 (DiLumen)K183112DiLumen內腔介入刀（“DiLumen IK™”）K182540DiLumen內腔介入平台 K173405DiLumen內腔介入剪刀（DiLumen Is）K173317DiLumen C2；DiLumen 工具固定座

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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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