FDA 510(k), K152319, Auris Robotic Endoscopy System (ARES)

FDA 510(k), K152319, Auris Robotic Endoscopy System (ARES)

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510(K) Number: K152319
Device Name: Auris Robotic Endoscopy System (ARES)
Manufacturer: MICHAEL A. DANIEL
Device Classification Name: Bronchoscope (Flexible Or Rigid)
Regulation Number: EOQ
Classification Product Code: KXA
Date Received: 08/17/2015
Decision Date: 05/26/2016
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Ear Nose & Throat
  • Status: Pending Fast-Track Request
  • Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity

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