Name: Predicase
Price: 199 USD

K-number	K251204
Device name	FUJIFILM Stiffening Wire Device (SW-2000)
Applicant	FUJIFILM Healthcare Americas Corporation
Product code	FDA
Device class	Class II
Decision date	Sep 26, 2025
Decision	Substantially Equivalent
Regulation	876.1500

AI Summary

The FDA summary PDF for this submission is not available in machine-readable form — common for older clearances. View on FDA's site →

Source

View the full FDA submission: accessdata.fda.gov

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FUJIFILM Stiffening Wire Device (SW-2000)

Everything you need for a 510(k) submission. Nothing you don't.