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 K241508
Device Name SKOUT® system
Applicant
Iterative Scopes, Inc.
14 Arrow Street
Floor 3
Cambridge,  MA  02138
Applicant Contact Caitlyn Seidl
Correspondent
Hogan Lovells US LLP
1735 Market St. Floor 23
Philadelphia,  PA  19103
Correspondent Contact Janice Hogan
Regulation Number876.1520
Classification Product Code
QNP  
Date Received05/28/2024
Decision Date 07/03/2024
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
-
-