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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 the device name listed in this FDA 510(k) record. The listed applicant is Medrobotics Corporation. It received FDA 510(k) clearance on 2017-05-04 under 510(k) 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. The listed applicant is Medrobotics Corporation. The 510(k) number is K162330.

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

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

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

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

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.

K172796Flex Robotic System and Flex Transabdominal DriveK170453Medrobotics Flex Robotic SystemK172036Medrobotics Flex Robotic System

Related Devices (Code: FDF)

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.

K261587Insufflation Retention Device (IRD) (11173-325-101)BPEndo, LLCK260423Disposable Endoscopic Distal AttachmentsYangzhou Fartley Medical Instrument Technology Co., Ltd.K252457Disposable Distal End Tape HoodShanghai SeeGen Photoelectric Technology Co., Ltd.K244029ROBOPERA (ER-R-002); ROBOPERA (ER-R-003)Endorobotics Co., Ltd.K243261FUJIFILM Endoscope Model EC-860P/M; FUJIFILM Endoscope Model EC-860P/L; FUJIFILM Endoscope Model EC-860S/LFujifilm CorporationK250432Colonovideoscope (CF-EZ1500DL); Colonovideoscope (CF-EZ1500DI); Gastrointestinal Videoscope (GIF-EZ1500)Olympus Medical Systems Corporation

Official Source

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

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