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Coapt LLC

FDA Regulatory Profile

Summary

Total Recalls
2
510(k) Clearances
5
Inspections
5
Compliance Actions
1

Recent Recalls

NumberClassProductDate
Z-0204-2024Class IICoapt ControlSeal Electrode, cutaneous EMG ElectrodeOctober 2, 2023
Z-0203-2024Class IICoapt Dome Electrode, Gen2 system, cutaneous electrodeOctober 2, 2023

Recent 510(k) Clearances

K-NumberDeviceDate
K223738Alpha Control Liner System (ACLS)January 11, 2023
K223605ControlSeal Electrode (ELSB)December 30, 2022
K191083COMPLETE CONTROL System Gen2May 24, 2019
K190416Dome ElectrodeApril 4, 2019
K162891Complete Control SystemApril 14, 2017