• 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 biopsy needle
510(k) Number K180037
Device Name Beacon EUS Access System
Covidien llc
15 Hampshire Street
Mansfield,  MA  02048
Applicant Contact Rachel Silva
Covidien llc
15 Hampshire Street
Mansfield,  MA  02048
Correspondent Contact Rachel Silva
Regulation Number876.1075
Classification Product Code
Date Received01/05/2018
Decision Date 04/26/2018
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
Recalls CDRH Recalls