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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 the device name listed in this FDA 510(k) record. The listed applicant is Medrobotics Corporation. It received FDA 510(k) clearance on 2018-01-18 under 510(k) 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. The listed applicant is Medrobotics Corporation. The 510(k) number is K172796.

When did Flex Robotic System and Flex Transabdominal Drive receive FDA 510(k) clearance?

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

Who is the listed applicant for Flex Robotic System and Flex Transabdominal Drive?

The FDA 510(k) record lists Medrobotics Corporation as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing Medrobotics Corporation as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K170453Medrobotics Flex Robotic SystemK172036Medrobotics Flex Robotic SystemK162330Flex Robotic System and Flex Colorectal Drive

Related Devices (Code: HET)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K250939SIRIUS Endoscope System (PR-SI-1230)Precision Robotics (Hong Kong) LimitedK243821i-CutA.M.I. Agency For Medical Innovations GmbHK221642SIRIUS Endoscope SystemPrecision Robotics (Hong Kong) LimitedK210116Video Endoscopy System, 3D Video Endoscopy SystemSurgnova Healthcare Technologies (Zhejiang) Co., Ltd.K201832Endoeye Flex Deflectable Videoscope Olympus LTF-S190-5Olympus Medical Systems Corp.K210104SurroundScope System270surgical , Ltd.

Official Source

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