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 Temporary Tissue Marker
510(k) Number K163541
Device Name Magseed Magnetic Marker System
Applicant
Endomagnetics Ltd.,
The Jeffreys Bldg., Cowley Rd.
Cambridge,  GB CB4 0WS
Applicant Contact ANDREW SHAWCROSS
Correspondent
Endomagnetics Ltd.,
The Jeffreys Bldg., Cowley Rd.
Cambridge,  GB CB4 0WS
Correspondent Contact ANDREW SHAWCROSS
Regulation Number878.4300
Classification Product Code
PBY  
Date Received12/16/2016
Decision Date 01/13/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-