K233229
- 510(k) number
- K233229
- Device name
- NaviCam Small Bowel Capsule Endoscopy System with NaviCam SB Capsule and NaviCam Tether
- Applicant
- Anx Robotica Corporation TX · US
- Product code
- NEZ — System, Imaging, Gastrointestinal, Wireless, Capsule
- Decision date
- 2024-01-05
- Date received
- 2023-09-28
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 1.1 MB · U.S. public domain
Also available from FDA: K233229.pdf
Official FDA record: K233229
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.