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 System, Imaging, Gastrointestinal, Wireless, Capsule
510(k) Number K242643
Device Name CapsoCam Plus (SV-3) Capsule Endoscopy System
Applicant
CapsoVision Inc.
18805 Cox Avenue
Suite 250
Saratoga,  CA  95070
Applicant Contact Azimun Jamal
Correspondent
CapsoVision Inc.
18805 Cox Avenue
Suite 250
Saratoga,  CA  95070
Correspondent Contact Zane Liu
Regulation Number876.1300
Classification Product Code
NEZ  
Date Received09/03/2024
Decision Date 12/04/2024
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
Predetermined Change
Control Plan Authorized		 No
-
-