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 K230991
Device Name PillCam SB 3 capsule endoscopy system, PillCam Software 9.0E
Applicant
Given Imaging Ltd. (Medtronic)
2 Hacarmel St. New Industrial Park
P.O. Box 258
Yoqneam Northern,  IL 20692
Applicant Contact Breanna Hessler
Correspondent
Given Imaging Ltd. (Medtronic)
2 Hacarmel St. New Industrial Park
P.O. Box 258
Yoqneam Northern,  IL 20692
Correspondent Contact Breanna Hessler
Regulation Number876.1300
Classification Product Code
NEZ  
Date Received04/06/2023
Decision Date 06/30/2023
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
-
-