K243296
- 510(k) number
- K243296
- Device name
- Disposable Biopsy Needle
- Applicant
- Carbon (Shenzhen) Medical Device Co., Ltd. CN
- Product code
- KNW — Instrument, Biopsy
- Decision date
- 2025-07-11
- Date received
- 2024-10-18
- 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: K243296.pdf
Official FDA record: K243296
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.