K233031
- 510(k) number
- K233031
- Device name
- M·Biopsy /SureCore Automatic Disposable Biopsy Needle, M·Biopsy /SureCore Semi-automatic Disposable Biopsy Needle, M·Biopsy /SureAim Coaxial Biopsy Needle
- Applicant
- Canyon Medical, Inc. CN
- Product code
- KNW — Instrument, Biopsy
- Decision date
- 2024-01-17
- Date received
- 2023-09-25
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 2.8 MB · U.S. public domain
Also available from FDA: K233031.pdf
Official FDA record: K233031
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.