• 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 bronchoscope (flexible or rigid)
510(k) Number K152319
Device Name Auris Robotic Endoscopy System (ARES)
Applicant
AURIS SURGICAL ROBOTICS, INC.
125 SHOREWAY ROAD, SUITE D
san carlos,  CA  94070
Applicant Contact michael a. daniel
Correspondent
DANIEL & DANIEL CONSULTING, LLC
340 JONES LANE
gardnerville,  NV  89460
Correspondent Contact michael a. daniel
Regulation Number874.4680
Classification Product Code
EOQ  
Date Received08/17/2015
Decision Date 05/26/2016
Decision substantially equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-