FDA 510(k)

Fibresolve (with PCCP)

K-Number: K252041 · 2025-11-07

Decision Date2025-11-07

Product CodeQWO

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

Fibresolve (with PCCP) is the device name listed in this FDA 510(k) record. The listed applicant is Imvaria, Inc.. It received FDA 510(k) clearance on 2025-11-07 under 510(k) 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. The listed applicant is Imvaria, Inc.. The 510(k) number is K252041.

When did Fibresolve (with PCCP) receive FDA 510(k) clearance?

Fibresolve (with PCCP) received FDA 510(k) clearance on 2025-11-07, under 510(k) number K252041.

Who is the listed applicant for Fibresolve (with PCCP)?

The FDA 510(k) record lists Imvaria, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Fibresolve (with PCCP)?

The FDA product code for Fibresolve (with PCCP) is QWO.

Other records listing Imvaria, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K241891ScreenDx

Related Devices (Code: QWO)

K241891ScreenDxImvaria, Inc.K242467IQ-UIPImbio, Inc.

Official Source

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