FDA 510(k)

電熱切刀（平刀）DK2620JI 及 DK2623JI

K 號：K220053 · 2022-02-04

決定日期2022-02-04

產品代碼KGE

諮詢委員會GU

決定相當於

器材摘要

Diathermic Slitter (FlushKnife) DK2620JI and DK2623JI is the device name listed in this FDA 510(k) record. The listed applicant is Fujifilm Corporation. It received FDA 510(k) clearance on 2022-02-04 under 510(k) number K220053. The device is classified under product code KGE. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Diathermic Slitter (FlushKnife) DK2620JI and DK2623JI?

Diathermic Slitter (FlushKnife) DK2620JI and DK2623JI is a medical device that received FDA 510(k) clearance on 2022-02-04. The listed applicant is Fujifilm Corporation. The 510(k) number is K220053.

When did Diathermic Slitter (FlushKnife) DK2620JI and DK2623JI receive FDA 510(k) clearance?

Diathermic Slitter (FlushKnife) DK2620JI and DK2623JI received FDA 510(k) clearance on 2022-02-04, under 510(k) number K220053.

Who is the listed applicant for Diathermic Slitter (FlushKnife) DK2620JI and DK2623JI?

FDA 510(k) 記錄中將富士通公司列為申請人。這並不單獨確立設備製造商的身份。

What is the FDA product code for Diathermic Slitter (FlushKnife) DK2620JI and DK2623JI?

The FDA product code for Diathermic Slitter (FlushKnife) DK2620JI and DK2623JI is KGE.

其他以 Fujifilm Corporation 為申請人之記錄

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相關器械（代碼：KGE）

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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