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 Implantable Transprostatic Tissue Retractor System
510(k) Number K173087
Device Name UroLift System (UL400 and UL500)
Applicant
Neotract, Inc.
4473 Willow Rd., Suite 100
Pleasanton,  CA  94588
Applicant Contact Louis-Pierre Marcoux
Correspondent
Neotract, Inc.
4473 Willow Rd., Suite 100
Pleasanton,  CA  94588
Correspondent Contact Louis-Pierre Marcoux
Regulation Number876.5530
Classification Product Code
PEW  
Date Received09/29/2017
Decision Date 12/28/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Clinical Trials NCT02625545
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
-
-