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CapsoVision, Inc.

United States·US-MF-000008446

Last updated September 17, 2026

Information

Device	Model / Reference	Registries	Class	Status
CapsoRetrieve	CVR1	FDA UDI	Class II	Active
CapsoCam Plus	SV-3	FDA UDI	Class II	Active
CapsoRetrieve	CVR1	FDA UDI	Class II	Active
CE Deliver (DLV)	K252480	FDA 510(k)	Class II	Active
CapsoCam Plus (SV-3) Capsule Endoscope System	K161773	FDA 510(k)	Class II	Active
CapsoCam Plus (SV-3) Capsule Endoscopy System	K242643	FDA 510(k)	Class II	Active
CapsoCam (SV-1)	K151635	FDA 510(k)	Class II	Active
CapsoCam Plus (SV-3)	K183192	FDA 510(k)	Class II	Active
CapsoCam Plus (SV-3) Capsule Endoscopy System	K192662	FDA 510(k)	Class II	Active
CapsoCloud	CapsoCloud	EUDAMEDFDA UDI	Class I	Active
CapsoAccess	CDAS3	EUDAMEDFDA UDI	Class I	Active
CapsoView	CVV	EUDAMEDFDA UDI	Class IIa	Active
CapsoCam Plus	CapsoCam Plus	EUDAMEDFDA UDI	Class IIa	Active

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Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Feb 26, 2020	Z-2536-2020	—	terminated	Ingestible video capsule system has capsule with incorrect capture mode which will not record data when the capsule is ingested by patients. If used, there is a risk of delay of diagnosis and the patient may need to repeat the exam.
Oct 18, 2019	Z-1827-2020	—	terminated	Capsule Endoscopy System: a defect present in the capsule window may be stressed through the production process and in the final package, which could cause the housing of the capsule to crack and leak when ingested. Fluid from the patient could leak in to the capsule, which may damage components inside the capsule and the patient data may not be retrieved; the patient may need to repeat the exam.
Jul 3, 2019	Z-2073-2020	—	terminated	Possible mis-labeling of the device with incorrect serial number labels which may result in a patient's misdiagnosis.