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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Nasopharyngoscope (Flexible Or Rigid)
510(k) Number K170453
Device Name Medrobotics Flex Robotic System
Applicant
Medrobotics Corporation
475 Paramount Dr.
Raynham,  MA  02767
Applicant Contact John D. Bonasera
Correspondent
Medrobotics Corporation
475 Paramount Dr.
Raynham,  MA  02767
Correspondent Contact John D. Bonasera
Regulation Number874.4760
Classification Product Code
EOB  
Subsequent Product Codes
EOX   GCI  
Date Received02/15/2017
Decision Date 10/19/2017
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
Predetermined Change
Control Plan Authorized		 No
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