• 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 gastroscope and accessories, flexible/rigid
510(k) Number K152182
Device Name Fuse Gastroscopy System
Applicant
ENDOCHOICE INC.
11810 WILLS RD.
ALPHARETTA,  GA  30009
Applicant Contact DANIEL HOEFER
Correspondent
ENDOCHOICE INC.
11810 WILLS RD.
ALPHARETTA,  GA  30009
Correspondent Contact DANIEL HOEFER
Regulation Number876.1500
Classification Product Code
FDS  
Date Received08/05/2015
Decision Date 12/10/2015
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
-
-