K233109
- 510(k) number
- K233109
- Device name
- TP Pivot Pro Needle Guide
- Applicant
- Civco Medical Solutions IA · US
- Product code
- ITX — Transducer, Ultrasonic, Diagnostic
- Decision date
- 2023-12-22
- Date received
- 2023-09-27
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 1.5 MB · U.S. public domain
Also available from FDA: K233109.pdf
Official FDA record: K233109
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.