K-number	K252041
Device name	Fibresolve (with PCCP)
Applicant	Imvaria, Inc.
Product code	QWO
Device class	Class II
Decision date	Nov 7, 2025
Decision	Substantially Equivalent
Regulation	892.2085

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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Fibresolve (with PCCP)

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