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FDA 510(k)

Flex Robotic System and Flex Colorectal Drive

K-Number: K162330 · 2017-05-04

ApplicantMedrobotics Corporation
Decision Date2017-05-04
Product CodeFDF
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Flex Robotic System and Flex Colorectal Drive is a medical device manufactured by Medrobotics Corporation. It received FDA 510(k) clearance on 2017-05-04 under approval number K162330. The device is classified under product code FDF. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Flex Robotic System and Flex Colorectal Drive?

Flex Robotic System and Flex Colorectal Drive is a medical device that received FDA 510(k) clearance on 2017-05-04. It is manufactured by Medrobotics Corporation. The 510(k) number is K162330.

When was Flex Robotic System and Flex Colorectal Drive approved by the FDA?

Flex Robotic System and Flex Colorectal Drive received FDA 510(k) clearance on 2017-05-04, under approval number K162330.

What company makes Flex Robotic System and Flex Colorectal Drive?

Flex Robotic System and Flex Colorectal Drive is manufactured by Medrobotics Corporation.

What is the FDA product code for Flex Robotic System and Flex Colorectal Drive?

The FDA product code for Flex Robotic System and Flex Colorectal Drive is FDF.

Related Clinical Trials

NCT05321134 Evaluation of SINGLE PORT (SP) Robotic Technology in Colorectal Surgery RECRUITING 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 NCT07034521 The Feasibility and Therapeutic Effect of Hybrid End-effector Robot-assisted Gait Training With an Active-assisted Module in Chronic Stroke Survivors RECRUITING

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

K170453Medrobotics Flex Robotic System K172036Medrobotics Flex Robotic System K172796Flex Robotic System and Flex Transabdominal Drive

Related Devices (Code: FDF)

K162428DiLumen Endolumenal Interventional PlatformLumendi, LLC K162622Fujifilm Endoscope Models EC-600HL and EC-600LSFujifilm Medical Systems U.S.A, Inc. K160015Pure VuMotus GI Medical Technologies , Ltd. K161355invendoscopy E200 SystemInvendo Medical GmbH K161791Aer-O-Scope Colonoscope SystemGi View , Ltd. K160356Third Eye Panoramic Auxiliary Endoscopy System - ResposableAvantis Medical Systems, Inc.

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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