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 Gastrointesinal Lesion Software Detection System
510(k) Number K252586
Device Name CADDIE
Applicant
Odin Medical Limited
74 Rivington St.
London,  GB EC2A3AY
Applicant Contact Luke Sampson
Correspondent
Odin Medical Limited
74 Rivington St.
London,  GB EC2A3AY
Correspondent Contact Luke Sampson
Regulation Number876.1520
Classification Product Code
QNP  
Subsequent Product Code
SBX  
Date Received08/15/2025
Decision Date 09/12/2025
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
Predetermined Change
Control Plan Authorized		 No
-
-