K250994
- 510(k) number
- K250994
- Device name
- ClearTip FNA and FNB Types
- Applicant
- Finemedix Co., Ltd. KR
- Product code
- FCG — Biopsy Needle
- Decision date
- 2025-08-21
- Date received
- 2025-04-01
- 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: K250994.pdf
Official FDA record: K250994
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.