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 Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection
510(k) Number K915506
Device Name LAPAROSCOPIC CHOLANGIOGRAM CATHETER KIT
Applicant
UNITED STATES ENDOSCOPY GROUP, INC.
9300 PROGRESS PKWY.
MENTOR,  OH  44060
Applicant Contact LISA M SCHOLZ
Correspondent
UNITED STATES ENDOSCOPY GROUP, INC.
9300 PROGRESS PKWY.
MENTOR,  OH  44060
Correspondent Contact LISA M SCHOLZ
Regulation Number876.5010
Classification Product Code
GCA  
Date Received12/09/1991
Decision Date 03/06/1992
Decision Substantially Equivalent - Kit (SESK)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-