Cleared Special

K141598 - FUSE COLONOSCOPY SYSTEM

K141598 is an FDA 510(k) clearance for FUSE COLONOSCOPY SYSTEM, manufactured by Endochoice, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FDF cleared through the Special 510(k) pathway after a 109-day FDA review.

K141598 · Endochoice, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2014
Decision
109d
Days
Class 2
Risk

K141598 is an FDA 510(k) clearance for the FUSE COLONOSCOPY SYSTEM. Classified as Colonoscope And Accessories, Flexible/rigid (product code FDF), Class II - Special Controls.

Submitted by Endochoice, Inc. (Caesarea, IL). The FDA issued a Cleared decision on September 30, 2014 after a review of 109 days - within the typical 510(k) review window.

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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K141598

510(k) Number K141598 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 13, 2014
Decision Date September 30, 2014
Days to Decision 109 days
Submission Type Special
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
22d faster than avg
Panel avg: 131d · This submission: 109d
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 112
Devices cleared under the same product code (FDF) and FDA review panel - the closest regulatory comparables to K141598.
FUJIFILM Endoscope Models EC-600HL and EC-600LS
K143732 · Fujifilm Medical Systems U.S.A, Inc. · Jul 2015
THIRD EYE PANORAMIC AUXILIARY ENDOSCOPY SYSTEM
K140595 · Avantis Medical Systems, Inc. · Nov 2014
AER-O-SCOPE COLONOSCOPE SYSTEM
K141286 · Gi View , Ltd. · Sep 2014
PENTAX VIDEO COLONOSCOPES (EC FAMILY)
K131855 · Pentax Medical Company · Apr 2014
FUSE 1C COLONOSCOPY SYSTEM
K132839 · Endochoice, Inc. · Feb 2014
FUJIFILM 600 SERIES ENDOSCOPES
K132210 · Fujifilm Medical Systems U.S.A, Inc. · Jan 2014