K250493
- 510(k) number
- K250493
- Device name
- MotiliCap GI Monitoring System
- Applicant
- Anx Robotica Corporation TX · US
- Product code
- NYV — Gastrointestinal Motility System, Capsule
- Decision date
- 2025-05-21
- Date received
- 2025-02-20
- 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: K250493.pdf
Official FDA record: K250493
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.