Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Medrobotics Flex Robotic System

K-Number: K172036 · 2017-08-03

ApplicantMedrobotics Corporation
Decision Date2017-08-03
Product CodeFDF
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Medrobotics Flex Robotic System is the device name listed in this FDA 510(k) record. The listed applicant is Medrobotics Corporation. It received FDA 510(k) clearance on 2017-08-03 under 510(k) number K172036. 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 Medrobotics Flex Robotic System?

Medrobotics Flex Robotic System is a medical device that received FDA 510(k) clearance on 2017-08-03. The listed applicant is Medrobotics Corporation. The 510(k) number is K172036.

When did Medrobotics Flex Robotic System receive FDA 510(k) clearance?

Medrobotics Flex Robotic System received FDA 510(k) clearance on 2017-08-03, under 510(k) number K172036.

Who is the listed applicant for Medrobotics Flex Robotic System?

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 Medrobotics Flex Robotic System?

The FDA product code for Medrobotics Flex Robotic System 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 SystemK162330Flex Robotic System and Flex Colorectal Drive

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

View on FDA Database →

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

↑