Chrysalis Intelligence · Sponsors · Coapt

Coapt

Chicago, IL, US · 2 510(k) clearances · 2 recalls

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Total clearances

2

2022-12-30 → 2023-01-11

Last 12 months

0

Product codes

1

Most recent

2023-01-11

Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code	Device name	Class	Specialty	Clearances	Most recent
GXY	Electrode, Cutaneous	Class II	Neurology	2	2023-01-11

Safety

Recalls (2)

Class I (serious)

0

Risk of injury / death

Total recalls

2

Currently ongoing

2

Most recent

2023-10-02

Date	Severity	Status	Recall #	Product	Code	Reason
2023-10-02	Class II	Ongoing	Z-0204-2024	Coapt ControlSeal Electrode, cutaneous EMG Electrode	—	Patient may experience minor burn or blistering if device is exposed to direct sunlight and/or warm temperatures for over 12 hours or battery is damaged.
2023-10-02	Class II	Ongoing	Z-0203-2024	Coapt Dome Electrode, Gen2 system, cutaneous electrode	—	Patient may experience minor burn or blistering if device is exposed to direct sunlight and/or warm temperatures for over 12 hours or battery is damaged.

Filings

All 510(k) clearances (2)

Date	K-number	Device	Code	Class	Specialty
2023-01-11	K223738	Alpha Control Liner System (ACLS)	GXY	Class II	Neurology
2022-12-30	K223605	ControlSeal Electrode (ELSB)	GXY	Class II	Neurology