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FDA 510(k)

Flex Robotic System and Flex Transabdominal Drive

K-Number: K172796 · 2018-01-18

ApplicantMedrobotics Corporation
Decision Date2018-01-18
Product CodeHET
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Flex Robotic System and Flex Transabdominal Drive is a medical device manufactured by Medrobotics Corporation. It received FDA 510(k) clearance on 2018-01-18 under approval number K172796. The device is classified under product code HET. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Flex Robotic System and Flex Transabdominal Drive?

Flex Robotic System and Flex Transabdominal Drive is a medical device that received FDA 510(k) clearance on 2018-01-18. It is manufactured by Medrobotics Corporation. The 510(k) number is K172796.

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

Flex Robotic System and Flex Transabdominal Drive received FDA 510(k) clearance on 2018-01-18, under approval number K172796.

What company makes Flex Robotic System and Flex Transabdominal Drive?

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

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

The FDA product code for Flex Robotic System and Flex Transabdominal Drive is HET.

Related Clinical Trials

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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 K162330Flex Robotic System and Flex Colorectal 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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