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 K192101
Device Name Medone Ultra, Medextra
Applicant
Medax Srl Unipersonale
Via R.Piva, 1/A
Poggio Rusco,  IT 46025
Applicant Contact Stefano Cavalieri
Correspondent
Gemarmed S.R.L
Via R. Piva 1/A
Poggio Rusco,  IT 46025
Correspondent Contact Stefano Cavalieri
Regulation Number876.1075
Classification Product Code
KNW  
Date Received08/05/2019
Decision Date 04/02/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-