K250469
- 510(k) number
- K250469
- Device name
- Accuro® 3S Needle Guide Kit
- Applicant
- Rivanna Medical, Inc. VA · US
- Product code
- ITX — Transducer, Ultrasonic, Diagnostic
- Decision date
- 2025-06-13
- Date received
- 2025-02-18
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 2.8 MB · U.S. public domain
Also available from FDA: K250469.pdf
Official FDA record: K250469
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.