K242128
- 510(k) number
- K242128
- Device name
- Forsvall biopsy needle system for prostate biopsy (Forsvall biopsy gun and Forsvall biopsy needle)
- Applicant
- Xaga Surgical SE
- Product code
- KNW — Instrument, Biopsy
- Decision date
- 2025-02-27
- Date received
- 2024-07-19
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
510(k) Summary (official FDA PDF): K242128.pdf
Official FDA record: K242128
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.