Fibresolve (with PCCP)
K-Number: K252041 · 2025-11-07
ApplicantImvaria, Inc.
Decision Date2025-11-07
Product CodeQWO
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Fibresolve (with PCCP) is a medical device manufactured by Imvaria, Inc.. It received FDA 510(k) clearance on 2025-11-07 under approval number K252041. The device is classified under product code QWO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Fibresolve (with PCCP)?
Fibresolve (with PCCP) is a medical device that received FDA 510(k) clearance on 2025-11-07. It is manufactured by Imvaria, Inc.. The 510(k) number is K252041.
When was Fibresolve (with PCCP) approved by the FDA?
Fibresolve (with PCCP) received FDA 510(k) clearance on 2025-11-07, under approval number K252041.
What company makes Fibresolve (with PCCP)?
Fibresolve (with PCCP) is manufactured by Imvaria, Inc..
What is the FDA product code for Fibresolve (with PCCP)?
The FDA product code for Fibresolve (with PCCP) is QWO.
Other Devices by Imvaria, Inc.
Related Devices (Code: QWO)
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.