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 submucosal injection agent
510(k) Number K180068
Device Name ORISE Gel
Applicant
Boston Scientific
100 Boston Scientific Way
Marlborough,  MA  01752
Applicant Contact Thomas Hirte
Correspondent
Boston Scientific
100 Boston Scientific Way
Marlborough,  MA  01752
Correspondent Contact Jennifer Edouard
Regulation Number876.1500
Classification Product Code
PLL  
Date Received01/09/2018
Decision Date 09/28/2018
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
Recalls CDRH Recalls
-
-