Company · US

Coapt, LLC

FDA 510(k) clearances and medical device recalls filed under this name, 2017 to 2023. Name variants (Inc, Corp, punctuation) are merged.

5510(k) clearances (0 in 12 months)

2recalls (0 in 12 months)

2recalls that name a 510(k)

Product codes

Code	Device	Records
GXY	Electrode, Cutaneous	7

Decided	510(k)	Device and applicant	Code
Jan 11, 2023	K223738	Alpha Control Liner System (ACLS) Coapt	GXY
Dec 30, 2022	K223605	ControlSeal Electrode (ELSB) Coapt	GXY
May 24, 2019	K191083	COMPLETE CONTROL System Gen2 Coapt, LLC	GXY
Apr 4, 2019	K190416	Dome Electrode Coapt, LLC	GXY
Apr 14, 2017	K162891	Complete Control System Coapt, LLC	GXY

Date	Firm and product	Code	Linked 510(k)
Oct 31, 2023	Coapt LLC Coapt ControlSeal Electrode, cutaneous EMG Electrode Open, Classified	GXY	K223605
Oct 31, 2023	Coapt LLC Coapt Dome Electrode, Gen2 system, cutaneous electrode Open, Classified	GXY	K190416