K252646
- 510(k) number
- K252646
- Device name
- Single-Use Fine Needle Biopsy (FNB) device (NA-U210H)
- Applicant
- Olympus Medical Systems Corp. JP
- Product code
- FCG — Biopsy Needle
- Decision date
- 2025-10-24
- Date received
- 2025-08-21
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 0.7 MB · U.S. public domain
Also available from FDA: K252646.pdf
Official FDA record: K252646
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.