Cleared Special

K172036 - Medrobotics Flex Robotic System

K172036 is an FDA 510(k) clearance for Medrobotics Flex Robotic System, manufactured by Medrobotics Corporation. The device is a Class 2 Gastroenterology & Urology device with product code FDF cleared through the Special 510(k) pathway after a 29-day FDA review.

K172036 · Medrobotics Corporation · Gastroenterology & Urology device
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Aug 2017
Decision
29d
Days
Class 2
Risk

K172036 is an FDA 510(k) clearance for the Medrobotics Flex Robotic System. Classified as Colonoscope And Accessories, Flexible/rigid (product code FDF), Class II - Special Controls.

Submitted by Medrobotics Corporation (Raynham, US). The FDA issued a Cleared decision on August 3, 2017 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1500 - the FDA gastroenterology and urology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Medrobotics Corporation devices

FDA 510(k) Submission Details - K172036

510(k) Number K172036 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 05, 2017
Decision Date August 03, 2017
Days to Decision 29 days
Submission Type Special
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
101d faster than avg
Panel avg: 130d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

FDF Device Classification - Class 2, Special Controls

Product Code FDF Colonoscope And Accessories, Flexible/rigid
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition To Examine Or Perform Procedures In The Colon Or Rectum For Reusable, Flexible Endoscopes In This Product Code, Validated Reprocessing Instructions And Reprocessing Validation Data Must Be Included In A 510(k) Submission (82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - FDF Colonoscope And Accessories, Flexible/rigid

All 75
Devices cleared under the same product code (FDF) and FDA review panel - the closest regulatory comparables to K172036.
FUJIFILM Endoscope Models EC-600HL and EC-600LS
K180405 · Fujifilm Corporation · Mar 2018
Focus Cap
K171673 · Gce Medical Corporation · Jan 2018
invendoscopy E210 System
K173085 · Invendo Medical GmbH · Jan 2018
Oracle EUS Balloon
K163492 · United States Endoscopy Group, Inc. · Jan 2017
Fujifilm Endoscope Models EC-600HL and EC-600LS
K162622 · Fujifilm Medical Systems U.S.A, Inc. · Oct 2016
Fujifilm Video Colonoscope Model EC-600WL V2
K160196 · Fujifilm Medical Systems U.S.A, Inc. · Feb 2016