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FDA 510(k)

FUJIFILM Stiffening Wire Device (SW-2000)

K-Number: K251204 · 2025-09-26

ApplicantFUJIFILM Healthcare Americas Corporation
Decision Date2025-09-26
Product CodeFDA
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

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

Frequently Asked Questions

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. It is manufactured by FUJIFILM Healthcare Americas Corporation. The 510(k) number is K251204.

When was FUJIFILM Stiffening Wire Device (SW-2000) approved by the FDA?

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

What company makes FUJIFILM Stiffening Wire Device (SW-2000)?

FUJIFILM Stiffening Wire Device (SW-2000) is manufactured by FUJIFILM Healthcare Americas Corporation.

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.

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Related Devices (Code: FDA)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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