Medrobotics Flex Robotic System

Colonoscope And Accessories, Flexible/rigid

Medrobotics Corporation

The following data is part of a premarket notification filed by Medrobotics Corporation with the FDA for Medrobotics Flex Robotic System.

Pre-market Notification Details

Device IDK172036
510k NumberK172036
Device Name:Medrobotics Flex Robotic System
ClassificationColonoscope And Accessories, Flexible/rigid
Applicant Medrobotics Corporation 475 Paramount Drive Raynham,  MA  02767
ContactJohn D. Bonasera
CorrespondentJohn D. Bonasera
Medrobotics Corporation 475 Paramount Drive Raynham,  MA  02767
Product CodeFDF  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-07-05
Decision Date2017-08-03
Summary:summary

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