K230646
- 510(k) number
- K230646
- Device name
- SUREcore Prime Biopsy Instrument
- Applicant
- Uro-1 Medical, Inc. NC · US
- Product code
- KNW — Instrument, Biopsy
- Decision date
- 2023-11-29
- Date received
- 2023-03-08
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K230646.pdf
Official FDA record: K230646
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.