K233294
- 510(k) number
- K233294
- Device name
- Automatic Biopsy Needle BAM, Semi-Automatic Needle BIM
- Applicant
- Itp Innovative Tomography Products GmbH DE
- Product code
- KNW — Instrument, Biopsy
- Decision date
- 2024-06-18
- Date received
- 2023-09-29
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K233294.pdf
Official FDA record: K233294
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.