Cleared Traditional

K162330 - Flex Robotic System and Flex Colorectal Drive

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

K162330 · Medrobotics Corporation · Gastroenterology & Urology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

FDA 510(k) Submission Details - K162330

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
127d slower than avg
Panel avg: 131d · This submission: 258d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 112
Devices cleared under the same product code (FDF) and FDA review panel - the closest regulatory comparables to K162330.
invendoscopy E210 System
K173085 · Invendo Medical GmbH · Jan 2018
Pure-Vu System
K173392 · Motus GI Medical Technologies , Ltd. · Dec 2017
Medrobotics Flex Robotic System
K172036 · Medrobotics Corporation · Aug 2017
Oracle EUS Balloon
K163492 · United States Endoscopy Group, Inc. · Jan 2017
DiLumen Endolumenal Interventional Platform
K162428 · Lumendi, LLC · Dec 2016
Fujifilm Endoscope Models EC-600HL and EC-600LS
K162622 · Fujifilm Medical Systems U.S.A, Inc. · Oct 2016
K162330 · Flex Robotic System and Flex Colorectal Drive
Download PDF FDA Summary Medrobotics Corporati…