Cleared Traditional

K162330 - Flex Robotic System and Flex Colorectal...

K162330 is the FDA 510(k) clearance for Flex Robotic System and Flex Colorectal... by Medrobotics Corporation. It is a Class 2 Gastroenterology & Urology device (product code FDF) cleared through the Traditional 510(k) pathway after a 258-day FDA review.

K162330 · Medrobotics Corporation · Gastroenterology & Urology device
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May 2017
Decision
258d
Days
Class 2
Risk

K162330 is an FDA 510(k) clearance for the Flex Robotic System and Flex Colorectal Drive. 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 May 4, 2017 after a review of 258 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1500 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Medrobotics Corporation devices

Submission Details

510(k) Number K162330 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 19, 2016
Decision Date May 04, 2017
Days to Decision 258 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
128d slower than avg
Panel avg: 130d · This submission: 258d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 48
Devices cleared under the same product code (FDF) and FDA review panel - the closest regulatory comparables to K162330.
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