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 Hemostatic Metal Clip For The Gi Tract
510(k) Number K101428
Device Name OTSC (OVER-THE SCOPE-CLIP) SYSTEM SET
Applicant
Ovesco Endoscopy AG
Kastellstr. 8
Baden Wuerttemberg
Karlsruhe,  DE 76227
Applicant Contact ARNE BRIEST
Correspondent
Ovesco Endoscopy AG
Kastellstr. 8
Baden Wuerttemberg
Karlsruhe,  DE 76227
Correspondent Contact ARNE BRIEST
Regulation Number876.4400
Classification Product Code
PKL  
Date Received05/21/2010
Decision Date 12/01/2010
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
-
-