Cleared Traditional

K163495 - AdvanCE capsule endoscope delivery device

K163495 is the FDA 510(k) clearance for AdvanCE capsule endoscope delivery device by United States Endoscopy Group, Inc.. It is a Class 2 Gastroenterology & Urology device (product code NEZ) cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K163495 · United States Endoscopy Group, Inc. · Gastroenterology & Urology device
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Mar 2017
Decision
87d
Days
Class 2
Risk

K163495 is an FDA 510(k) clearance for the AdvanCE capsule endoscope delivery device. Classified as System, Imaging, Gastrointestinal, Wireless, Capsule (product code NEZ), Class II - Special Controls.

Submitted by United States Endoscopy Group, Inc. (Mentor, US). The FDA issued a Cleared decision on March 10, 2017 after a review of 87 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1300 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all United States Endoscopy Group, Inc. devices

Submission Details

510(k) Number K163495 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 13, 2016
Decision Date March 10, 2017
Days to Decision 87 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
43d faster than avg
Panel avg: 130d · This submission: 87d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NEZ System, Imaging, Gastrointestinal, Wireless, Capsule
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1300
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 - NEZ System, Imaging, Gastrointestinal, Wireless, Capsule

All 20
Devices cleared under the same product code (NEZ) and FDA review panel - the closest regulatory comparables to K163495.
MiroCam Capsule Endoscope System
K180732 · Intromedic Co., Ltd. · Nov 2018
Olympus Small Intestinal Capsule Endoscope System
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MiroCam Capsule Endoscope System
K170438 · Intromedic Co., Ltd. · Jan 2018
OLYMPUS SMALL INTESTINAL CAPSULE ENDOSCOPE SYSTEM
K163069 · Olympus Medical Systems Corp. · Jan 2017
ENDOCAPSULE SOFTWARE 10
K142680 · Olympus Medical Systems Corp. · Feb 2015
OLYMPUS SMALL INTESTINAL CAPSULE ENDOSCOPE SYSTEM
K123421 · Olympus Medical Systems Corp. · Apr 2013