K260517
- 510(k) number
- K260517
- Device name
- Automatic Core Biopsy Instrument
- Applicant
- Zhejiang Curaway Medical Technology Co., Ltd. CN
- Product code
- KNW — Instrument, Biopsy
- Decision date
- 2026-08-28
- Date received
- 2026-02-17
- 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: K260517.pdf
Official FDA record: K260517
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.