FDA 510(k)

富士通 stiffening wire device (SW-2000)

K 號：K251204 · 2025-09-26

申請人FUJIFILM Healthcare Americas Corporation

決定日期2025-09-26

產品代碼FDA

諮詢委員會GU

決定相當於

器材摘要

FUJIFILM Stiffening Wire Device (SW-2000) is the device name listed in this FDA 510(k) record. The listed applicant is FUJIFILM Healthcare Americas Corporation. It received FDA 510(k) clearance on 2025-09-26 under 510(k) number K251204. The device is classified under product code FDA. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the FUJIFILM Stiffening Wire Device (SW-2000)?

FUJIFILM Stiffening Wire Device (SW-2000) is a medical device that received FDA 510(k) clearance on 2025-09-26. The listed applicant is FUJIFILM Healthcare Americas Corporation. The 510(k) number is K251204.

When did FUJIFILM Stiffening Wire Device (SW-2000) receive FDA 510(k) clearance?

FUJIFILM Stiffening Wire Device (SW-2000) received FDA 510(k) clearance on 2025-09-26, under 510(k) number K251204.

Who is the listed applicant for FUJIFILM Stiffening Wire Device (SW-2000)?

The FDA 510(k) record lists FUJIFILM Healthcare Americas Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FUJIFILM Stiffening Wire Device (SW-2000)?

The FDA product code for FUJIFILM Stiffening Wire Device (SW-2000) is FDA.

其他以 FUJIFILM Healthcare Americas Corporation 為申請人之記錄

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相關器械（代碼：FDA）

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。

K260314Ancora-SBAspero Medical, Inc.K233321雙球囊內視鏡 EN-840T，超管 TS-1214CFUJIFILM Healthcare Americas Corporation K231323Ancora-SBAspero Medical, Inc.K223295內視鏡型號 EN-580T，過管 TS-1314B，氣球 BS-4，管套組 TY-500DFujifilm Corporaton K213195氣球 BS-3Fujifilm Corporation K191330Arc EnterocuffBoddingtons Plastics, Ltd.

官方來源

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