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 ear, nose, and throat stereotaxic instrument
510(k) Number K190532
Device Name TruDi NAV Wire
Applicant
Acclarent, Inc.
33 Technology Drive
Irvine,  CA  92618
Applicant Contact Leena Sorathia
Correspondent
Acclarent, Inc.
33 Technology Drive
Irvine,  CA  92618
Correspondent Contact Leena Sorathia
Regulation Number882.4560
Classification Product Code
PGW  
Date Received03/04/2019
Decision Date 05/03/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-