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 Instrument, Biopsy, Suction
510(k) Number K051637
Device Name DSNARE, MODEL 00711087
Applicant
UNITED STATES ENDOSCOPY GROUP, INC.
5976 HEISLEY RD.
MENTOR,  OH  44060
Applicant Contact GRETCHEN Y COHEN
Correspondent
UNITED STATES ENDOSCOPY GROUP, INC.
5976 HEISLEY RD.
MENTOR,  OH  44060
Correspondent Contact GRETCHEN Y COHEN
Regulation Number876.1075
Classification Product Code
FCK  
Subsequent Product Code
FDI  
Date Received06/20/2005
Decision Date 10/31/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-