K252795
- 510(k) number
- K252795
- Device name
- ZeniCore Automatic Biopsy Instrument (863212100 / ZeniCore Automatic Biopsy Device 12ga x 10cm with Coaxial Introducer Kit); ZeniCore Automatic Biopsy Instrument (863212130 / ZeniCore Automatic Biopsy Device 12ga x 13cm with Coaxial Introducer Kit); ZeniCore Automatic Biopsy Instrument (863214100 / ZeniCore Automatic Biopsy Device 14ga x 10cm with Coaxial Introducer Kit); ZeniCore Automatic Biopsy Instrument (863214130 / ZeniCore Automatic Biopsy Device 14ga x 13cm with Coaxial
- Applicant
- Argon Medical Devices, Inc. TX · US
- Product code
- KNW — Instrument, Biopsy
- Decision date
- 2026-02-23
- Date received
- 2025-09-02
- 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: K252795.pdf
Official FDA record: K252795
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.