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 Endoscope Channel Accessory
510(k) Number K103155
Device Name SUMO ACCESS AND TISSUE RESECTION SYSTEM
Applicant
Apollo Endosurgery, Inc.
7000 Bee Caves Rd.
Suite 350
Austin,  TX  78746
Applicant Contact GREG MATHISON
Correspondent
Apollo Endosurgery, Inc.
7000 Bee Caves Rd.
Suite 350
Austin,  TX  78746
Correspondent Contact GREG MATHISON
Regulation Number876.1500
Classification Product Code
ODC  
Date Received10/26/2010
Decision Date 10/28/2011
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
-
-