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FDA 510(k)

Medrobotics Flex Robotic System

K-Number: K170453 · 2017-10-19

ApplicantMedrobotics Corporation
Decision Date2017-10-19
Product CodeEOB
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

Medrobotics Flex Robotic System is a medical device manufactured by Medrobotics Corporation. It received FDA 510(k) clearance on 2017-10-19 under approval number K170453. The device is classified under product code EOB. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Medrobotics Flex Robotic System?

Medrobotics Flex Robotic System is a medical device that received FDA 510(k) clearance on 2017-10-19. It is manufactured by Medrobotics Corporation. The 510(k) number is K170453.

When was Medrobotics Flex Robotic System approved by the FDA?

Medrobotics Flex Robotic System received FDA 510(k) clearance on 2017-10-19, under approval number K170453.

What company makes Medrobotics Flex Robotic System?

Medrobotics Flex Robotic System is manufactured by Medrobotics Corporation.

What is the FDA product code for Medrobotics Flex Robotic System?

The FDA product code for Medrobotics Flex Robotic System is EOB.

Related Clinical Trials

NCT05391828 Persona MC vs PS RCT With ROSA RECRUITING NCT06690658 Self-Practicing Upper Body Exercises With a Robotic Trainer System RECRUITING NCT07606963 Triton 1.5 Robotic System for Diagnostic Colonoscopy NOT_YET_RECRUITING NCT07204925 Towards Efficient Personalization of Computerized Lower Limb Prostheses Via Reinforcement Learning in a Clinical Setup - Group 1 RECRUITING NCT07524699 A Study About Remote and Local Liver Surgery NOT_YET_RECRUITING NCT07566767 Effect of Robotic Gait on Functions in Cerebral Palsy COMPLETED

Related PubMed Literature

PMID: 42201559 Time-series and thematic analyses of clinical utilities and operational issues in early clinical studies of the da Vinci surgical system. Journal of robotic surgery (2026) PMID: 42174947 Aligning AI-Native 6G Healthcare Systems with EU Ethical and Legal Frameworks. Studies in health technology and informatics (2026) PMID: 41160299 Toward safe clinical deployment of remote robotic surgery in Japan: five-year validation of the hinotori™ system using 5G wireless communication. International journal of clinical oncology (2025)

Other Devices by Medrobotics Corporation

K172036Medrobotics Flex Robotic System K162330Flex Robotic System and Flex Colorectal Drive K172796Flex Robotic System and Flex Transabdominal Drive

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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