FDA 510(k)

富士胶片加固钢丝装置（SW-2000）

K号: K251204 · 2025-09-26

申请人FUJIFILM Healthcare Americas Corporation

决定日期2025-09-26

产品代码FDA

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决定实质等同

器械摘要

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.

常见问题

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.

列明FUJIFILM Healthcare Americas Corporation为申报人的其他记录

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