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 Laparoscope, General & Plastic Surgery
510(k) Number K093279
Device Name NAVIX ACCESS DEVICE
Applicant
XLUMENA
453 RAVENDALE DRIVE SUITE H
MOUNTAIN VIEW,  CA  94043
Applicant Contact WITNEY MCKIERNAN
Correspondent
XLUMENA
453 RAVENDALE DRIVE SUITE H
MOUNTAIN VIEW,  CA  94043
Correspondent Contact WITNEY MCKIERNAN
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received10/20/2009
Decision Date 04/07/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-