CapsoVision, Inc.
Saratoga, CA, US
CapsoVision, Inc. appears in FDA device records in Saratoga, CA. FDA records list 6 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 3 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
1 nameFDA records resolved to CapsoVision, Inc. carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Capso Vision, Inc.enforcement report, recall
510(k) clearance history
FDA records hold 6 510(k) clearances for CapsoVision, Inc. between 2016 and 2025. The busiest year on record is 2016, with 2. The most recent is 2025, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2016 | 2 |
| 2019 | 1 |
| 2020 | 1 |
| 2024 | 1 |
| 2025 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K252480 | CE Deliver (DLV) | NEZ | Substantially Equivalent | |
| K242643 | CapsoCam Plus (SV-3) Capsule Endoscopy System | NEZ | Substantially Equivalent | |
| K192662 | CapsoCam Plus (SV-3) Capsule Endoscopy System | NEZ | Substantially Equivalent | |
| K183192 | CapsoCam Plus (SV-3) | NEZ | Substantially Equivalent | |
| K161773 | CapsoCam Plus (SV-3) Capsule Endoscope System | NEZ | Substantially Equivalent | |
| K151635 | CapsoCam (SV-1) | NEZ | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3008062894 | 3008062894 | CapsoVision, Inc. | 18805 Cox Ave Ste 250, Saratoga, CA 95070 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2536-2020 | The CapsoCam Plus (SV-3); Device Common Name: System, Imaging, Gastrointestinal, Wireless, Capsule; Catalog Number 2795 - Product Usage: intended for visualization of the small bowel mucosa in adults. It may be used as a tool in the detection of abnormalities of the small bowel. | 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. | Class II | Terminated | |
| Z-1827-2020 | CapsoCAM Plus, UDI: 00867770000209 | 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. | Class II | Terminated | |
| Z-2073-2020 | CapsoCam Plus *** System, Imaging, Gastrointestinal, Wireless, Capsule, Electrical Rating 3.1V DC/10mA REF 2795 - Product Usage: The CapsoCam Plus video capsule system is intended for visualization of the small bowel mucosa in adults. It may be used as a tool in the detection of abnormalities of the small bowel. | Possible mis-labeling of the device with incorrect serial number labels which may result in a patient's misdiagnosis. | Class II | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain