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 biopsy needle
510(k) Number K160423
Device Name Perineologic Access Needle
Applicant
Corbin Clinical Resources, LLC
12234 Williams Road
Cumberland,  MD  21502
Applicant Contact Kenneth K. Kleinhenz
Correspondent
Corbin Clinical Resources, LLC
12234 Williams Road
Cumberland,  MD  21502
Correspondent Contact Kenneth K. Kleinhenz
Regulation Number876.1075
Classification Product Code
FCG  
Date Received02/16/2016
Decision Date 09/02/2016
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
-
-