Cleared Traditional

K160275 - Fuse Endoscopic System with FuseBox Pro...

K160275 is an FDA 510(k) clearance for Fuse Endoscopic System with FuseBox Pro..., manufactured by Endochoice, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code PEA cleared through the Traditional 510(k) pathway after a 181-day FDA review.

K160275 · Endochoice, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2016
Decision
181d
Days
Class 2
Risk

K160275 is an FDA 510(k) clearance for the Fuse Endoscopic System with FuseBox Processor. Classified as Endoscope, Accessories, Image Post-processing For Color Enhancement (product code PEA), Class II - Special Controls.

Submitted by Endochoice, Inc. (Alpharetta, US). The FDA issued a Cleared decision on August 1, 2016 after a review of 181 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 Endochoice, Inc. devices

FDA 510(k) Submission Details - K160275

510(k) Number K160275 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 02, 2016
Decision Date August 01, 2016
Days to Decision 181 days
Submission Type Traditional
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
51d slower than avg
Panel avg: 130d · This submission: 181d
Pathway characteristics
Predicate-based equivalence.

PEA Device Classification - Class 2, Special Controls

Product Code PEA Endoscope, Accessories, Image Post-processing For Color Enhancement
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition Alternative Mode Of Visualization Using Image Post-processing Algorithms Of The Received White Light Image For Color Enhancement.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Gastroenterology & Urology devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT02651857 Completed Interventional Industry-sponsored

Exploratory Study of Upper and Lower Endoscopic Fuse System

1000
Patients (est.)
Other
Purpose
Open label
Masking
Condition studied Gastrointestinal Diseases
Study design Single group
Eligibility All sexes · 18 Years+
Sponsor EndoChoice Inc. (industry)
Started 2015-11-01 → Primary completion 2017-04-27
Primary outcome
Performance, usability and ease of use (performance questionnaire)
Secondary outcome
Safety (adverse and severe adverse events)
Study completed - no results published. This trial concluded in 2017 but has not posted results to ClinicalTrials.gov. Completed studies without public results are common in industry-sponsored device trials; the data may be referenced in the 510(k) Summary PDF or remain unpublished.
View full study on ClinicalTrials.gov

Regulatory Peers - PEA Endoscope, Accessories, Image Post-processing For Color Enhancement

All 7
Devices cleared under the same product code (PEA) and FDA review panel - the closest regulatory comparables to K160275.
PENTAX Medical Video Processor EPK-i5500c, PENTAX Medical Video Upper GI Scope EG29-i10c, PENTAX Medical Video Colonoscope EC34-i10cL, PENTAX Medical Video Colonoscope EC38-i10cL
K190805 · Pentax of America, Inc. · Dec 2019
PENTAX Medical EPK-i7010 and PENTAX EPK-i5010 Video Processors with GI Family
K191282 · Pentax of America, Inc. · Nov 2019
PENTAX Medical EPK-i7010 Video Processor with EB Family of Scopes
K173679 · Pentax of America, Inc. · Jul 2018
PENTAX Medical EPK-i7010 Video Processor with GI Family
K150618 · Pentax of America, Inc. · Nov 2015
EPX-4440HD DIGITAL VIDEO PROCESSOR
K140149 · Fujifilm Medical Systems U.S.A, Inc. · Aug 2014