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Copan WASP

FDA Regulatory Profile

Summary

Total Recalls
1
510(k) Clearances
5
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1812-2025Class IIPhenoMATRIXMay 6, 2025

Recent 510(k) Clearances

K-NumberDeviceDate
K251511PhenoMATRIXJanuary 22, 2026
K232756ColibríDecember 27, 2023
K223245ColibríMarch 20, 2023
K220546Colibrí SystemOctober 5, 2022
K193138Colibri SystemDecember 27, 2021