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 dislodger, stone, biliary
510(k) Number K171915
Device Name Nathanson Transcystic Bile Duct Stone Exploration Pack
Applicant
Cook Incorporated
450 Daniels Way, P.O. Box 489
Bloomington,  IN  47402
Applicant Contact Colin Jacob
Correspondent
Cook Incorporated
450 Daniels Way, P.O. Box 489
Bloomington,  IN  47402
Correspondent Contact Colin Jacob
Regulation Number876.5010
Classification Product Code
LQR  
Date Received06/26/2017
Decision Date 03/01/2018
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
-
-