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 K172344
Device Name Medax Biopsy Systems II (MEDONE, MEDCUT, MEDEM, MEDBONE, MEDLOCK)
Applicant
Medax Srl Unipersonale
Via R.Piva, 1/A
Poggio Rusco,  IT 46025
Applicant Contact Stefano Cavalieri
Correspondent
Gemar S.R.L.
Via G. Puccini 1
Medolla,  IT I-41036
Correspondent Contact Mario Gennari
Regulation Number876.1075
Classification Product Code
KNW  
Date Received08/02/2017
Decision Date 11/13/2017
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
-
-