PhenoMATRIX
K-Number: K251511 · 2026-01-22
ApplicantCopan Wasp Srl
Decision Date2026-01-22
Product CodePPU
Advisory CommitteeMI
DecisionSubstantially Equivalent
Device Summary
PhenoMATRIX is a medical device manufactured by Copan Wasp Srl. It received FDA 510(k) clearance on 2026-01-22 under approval number K251511. The device is classified under product code PPU. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the PhenoMATRIX?
PhenoMATRIX is a medical device that received FDA 510(k) clearance on 2026-01-22. It is manufactured by Copan Wasp Srl. The 510(k) number is K251511.
When was PhenoMATRIX approved by the FDA?
PhenoMATRIX received FDA 510(k) clearance on 2026-01-22, under approval number K251511.
What company makes PhenoMATRIX?
PhenoMATRIX is manufactured by Copan Wasp Srl.
What is the FDA product code for PhenoMATRIX?
The FDA product code for PhenoMATRIX is PPU.
Other Devices by Copan Wasp Srl
Related Devices (Code: PPU)
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.