Data / Medical devices / United States / CapsoVision, Inc.
CapsoVision, Inc.: FDA-registered device maker in Saratoga, CA, United States, 7 510(k) clearances
CapsoVision, Inc. is registered with the FDA (registration 3008062894) in Saratoga, CA, United States. It lists 4 device types. The FDA files 7 510(k) clearances under its listings, the newest dated September 25, 2026. 3 recall events name it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3008062894
- Address
- 18805 Cox Ave Ste 250, Saratoga, CA, United States, 95070
- Owner or operator
- CapsoVision, Inc. (10030573)
- Roles
- Manufacturer
- First device listed
- April 12, 2013
- Registered through
- 2027
- Brand names listed
- CDAS1-Capso Data Access, CE Deliver (DLV), CVR1-CapsoRetrieve, CapsoAccess CDAS, CapsoCam (SV-1), CapsoCam Plus, CapsoCam Plus (SV-3), CapsoCam Plus (SV-3) Capsule Endoscopy System and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Bedpan | FOB | 1 | Manufacturer | accessdata.fda.gov |
| Gastrointestinal Capsule Endoscopy Analysis Software Device | QZF | 2 | Manufacturer | accessdata.fda.gov |
| Medical Device Data System | OUG | 1 | Manufacturer | accessdata.fda.gov |
| System, Imaging, Gastrointestinal, Wireless, Capsule | NEZ | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 25, 2026 | K254230 | CapsoView (CVV); CapsoCloud (CLD) | QZF | Substantially Equivalent | CapsoVision, Inc. | accessdata.fda.gov |
| December 19, 2025 | K252480 | CE Deliver (DLV) | NEZ | Substantially Equivalent | CapsoVision, Inc. | accessdata.fda.gov |
| December 4, 2024 | K242643 | CapsoCam Plus (SV-3) Capsule Endoscopy System | NEZ | Substantially Equivalent | CapsoVision, Inc. | accessdata.fda.gov |
| February 14, 2020 | K192662 | CapsoCam Plus (SV-3) Capsule Endoscopy System | NEZ | Substantially Equivalent | CapsoVision, Inc. | accessdata.fda.gov |
| April 19, 2019 | K183192 | CapsoCam Plus (SV-3) | NEZ | Substantially Equivalent | CapsoVision, Inc. | accessdata.fda.gov |
| October 21, 2016 | K161773 | CapsoCam Plus (SV-3) Capsule Endoscope System | NEZ | Substantially Equivalent | CapsoVision, Inc. | accessdata.fda.gov |
| February 9, 2016 | K151635 | CapsoCam (SV-1) | NEZ | Substantially Equivalent | CapsoVision, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| February 26, 2020 | 85540 | Class II | Terminated | 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 | 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. | accessdata.fda.gov |
| October 18, 2019 | 85378 | Class II | Terminated | 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; t | accessdata.fda.gov |
| July 3, 2019 | 85532 | Class II | Terminated | 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 muc | Possible mis-labeling of the device with incorrect serial number labels which may result in a patient's misdiagnosis. | accessdata.fda.gov |
Compare with other makers
- All makers of Medical Device Data System
- All makers of System, Imaging, Gastrointestinal, Wireless, Capsule
- All makers of Bedpan
Updated September 25, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.