FDA.report

510(k) K242128

Device
Forsvall biopsy needle system for prostate biopsy (Forsvall biopsy gun and Forsvall biopsy needle)
Applicant
Xaga Surgical
510(k) number
K242128
Product code
KNW
Decision
Substantially Equivalent (SESE)
Decision date
2025-02-27
Date received
2024-07-19
Regulation
876.1075
Classification name
Instrument, Biopsy
Medical specialty
Gastroenterology, Urology
Review panel
Gastroenterology, Urology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Related Records

Applicant Contact

Contact
Anders Grim
Address
Alnarpsgatan 81 Helsingborg SE SE-256 67 SE-256 67

FDA Registration Numbers

Source Documents

510(k) summary PDF

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