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 Snare, Flexible
510(k) Number K190512
Device Name SmartBand EMR Kit, SmartBand EMR Pack, SmartSnare
Applicant
Intelligent Endoscopy
4740 Commercial Park Ct, Suite 1
Clemmons,  NC  27012
Applicant Contact Melissa Clark
Correspondent
Intelligent Endoscopy
4740 Commercial Park Ct, Suite 1
Clemmons,  NC  27012
Correspondent Contact Melissa Clark
Regulation Number876.4300
Classification Product Code
FDI  
Date Received03/01/2019
Decision Date 11/22/2019
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
-
-