K242643
- 510(k) number
- K242643
- Device name
- CapsoCam Plus (SV-3) Capsule Endoscopy System
- Applicant
- CapsoVision, Inc. CA · US
- Product code
- NEZ — System, Imaging, Gastrointestinal, Wireless, Capsule
- Decision date
- 2024-12-04
- Date received
- 2024-09-03
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K242643.pdf
Official FDA record: K242643
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.