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 K061201
Device Name DSNARE DIMINUTIVE POLYPECTOMY AND SUCTION SYSTEM, MODEL 00711087
Applicant
UNITED STATES ENDOSCOPY GROUP, INC.
5976 HEISLEY RD.
MENTOR,  OH  44060
Applicant Contact MICHAEL WOLF
Correspondent
UNITED STATES ENDOSCOPY GROUP, INC.
5976 HEISLEY RD.
MENTOR,  OH  44060
Correspondent Contact MICHAEL WOLF
Regulation Number876.1075
Classification Product Code
FCK  
Date Received05/01/2006
Decision Date 05/30/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
-
-