K261196
- 510(k) number
- K261196
- Device name
- Promisemed VeriEcto Automatic Biopsy Needles
- Applicant
- Promisemed Hangzhou Meditech Co., Ltd. CN
- Product code
- KNW — Instrument, Biopsy
- Decision date
- 2026-05-12
- Date received
- 2026-04-13
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 1.2 MB · U.S. public domain
Also available from FDA: K261196.pdf
Official FDA record: K261196
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.