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 system, gastrointestinal motility (electrical)
510(k) Number K201106
Device Name IntraMarX 3D Radiopaque Marker
Applicant
AnX Robotica Corp.
1047 Serpentine Ln. Suite 100, Pleasanton
Pleasanton,  CA  94566
Applicant Contact Steven Gu
Correspondent
Emergo Global Consulting, LLC
2500 Bee Cave Rd, Bldg 1, Suite 300
Austin,  TX  78746
Correspondent Contact Randy Jiang
Regulation Number876.1725
Classification Product Code
FFX  
Date Received04/24/2020
Decision Date 05/21/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
-
-