510(k) K192662 ยท NEZ System, Imaging, Gastrointestinal, Wireless, Capsule
CapsoCam Plus (SV-3) Capsule Endoscopy System
| Applicant | CapsoVision, Inc., Saratoga CA, US |
| Decision | Substantially Equivalent, Feb 14, 2020 |
| Received | Sep 25, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K192662
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 26, 2020 | Capso Vision, Inc. 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. Terminated |
NEZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.