K231960
- 510(k) number
- K231960
- Device name
- NaviCam Xpress Stomach Capsule Endoscope System (NaviCam Xpress Stomach System) with NaviCam Capsule and NaviCam Tether
- Applicant
- Anx Robotica Corporation TX · US
- Product code
- QKZ — Magnetically Maneuvered Capsule Endoscopy System
- Decision date
- 2023-10-03
- Date received
- 2023-07-03
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K231960.pdf
Official FDA record: K231960
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.