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 Tubes, Gastrointestinal (And Accessories)
510(k) Number K130611
Device Name ENTUIT THRIVE BALLOON RETENTION GASTROSTOMY FEEDING TUBE
Applicant
Xeridiem Medical Devices
4700 S. Overland Dr.
Tucson,  AZ  85714
Applicant Contact MICHELLE LOTT
Correspondent
Xeridiem Medical Devices
4700 S. Overland Dr.
Tucson,  AZ  85714
Correspondent Contact MICHELLE LOTT
Regulation Number876.5980
Classification Product Code
KNT  
Date Received03/07/2013
Decision Date 12/19/2013
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
-
-