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 K101200
Device Name PILLCAM EXPRESS VIDEO CAPSULES DELIVERY DEVICE
Applicant
GIVEN IMAGING LTD.
SHAAR YOKNEAM (HERMON BUILDING
NEW INDUSTRIAL ZONE,
YOKNEAM (P.O.BOX 258),  IL 20692
Applicant Contact Tim Thomas
Correspondent
GIVEN IMAGING LTD.
SHAAR YOKNEAM (HERMON BUILDING
NEW INDUSTRIAL ZONE,
YOKNEAM (P.O.BOX 258),  IL 20692
Correspondent Contact Tim Thomas
Regulation Number876.1300
Classification Product Code
NEZ  
Date Received04/29/2010
Decision Date 09/30/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Clinical Trials NCT01088646
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
-
-