K241934
- 510(k) number
- K241934
- Device name
- NaviCam Xpress Stomach Capsule Endoscope System (NaviCam Xpress Stomach System) with NaviCam Stomach Capsule/Tether (NaviCam Xpress Stomach System with NaviCam Capsule/Tether)
- Applicant
- Anx Robotica Corp TX · US
- Product code
- QKZ — Magnetically Maneuvered Capsule Endoscopy System
- Decision date
- 2024-07-31
- Date received
- 2024-07-02
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 1.3 MB · U.S. public domain
Also available from FDA: K241934.pdf
Official FDA record: K241934
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.