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 Endoscopic Access Overtube, Gastroenterology-Urology
510(k) Number K191067
Device Name Arc Endocuff Glide AEG110 & AEG120
Applicant
Boddingtons Plastics, Ltd.
Wheelbarrow Park Estate, Pattenden Ln., Marden
Tonbridge,  GB TN12 9QJ
Applicant Contact Shimaa Elsawy
Correspondent
Boddingtons Plastics, Ltd.
Wheelbarrow Park Estate, Pattenden Ln., Marden
Tonbridge,  GB TN12 9QJ
Correspondent Contact Shimaa Elsawy
Regulation Number876.1500
Classification Product Code
FED  
Date Received04/22/2019
Decision Date 05/30/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-