K241793
- 510(k) number
- K241793
- Device name
- Automatic Core Biopsy Instrument/ Semi-Automatic Core Biopsy Instrument/ Disposable Coaxial Biopsy Needle
- Applicant
- Zhejiang Curaway Medical Technology Co., Ltd. CN
- Product code
- KNW — Instrument, Biopsy
- Decision date
- 2025-01-24
- Date received
- 2024-06-21
- 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: K241793.pdf
Official FDA record: K241793
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.