Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Instrument, Biopsy
510(k) Number K242128
Device Name Forsvall biopsy needle system for prostate biopsy (Forsvall biopsy gun and Forsvall biopsy needle)
Applicant
Xaga Surgical
Alnarpsgatan 81
Helsingborg,  SE SE-256 67
Applicant Contact Anders Grim
Correspondent
Xaga Surgical
Lliongränden 320
Lund,  SE SE-224 71
Correspondent Contact Michael Lundh
Regulation Number876.1075
Classification Product Code
KNW  
Date Received07/19/2024
Decision Date 02/27/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-