Cleared Traditional

OLYMPUS SMALL INTESTINAL CAPSULE ENDOSCOPE SYSTEM (K163069) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K163069 · Olympus Medical Systems Corp. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2017
Decision
78d
Days
Class 2
Risk

K163069 is an FDA 510(k) clearance for the OLYMPUS SMALL INTESTINAL CAPSULE ENDOSCOPE SYSTEM. Classified as System, Imaging, Gastrointestinal, Wireless, Capsule (product code NEZ), Class II - Special Controls.

Submitted by Olympus Medical Systems Corp. (Hachioji, JP). The FDA issued a Cleared decision on January 19, 2017 after a review of 78 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 Olympus Medical Systems Corp. devices

Submission Details

510(k) Number K163069 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 02, 2016
Decision Date January 19, 2017
Days to Decision 78 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
52d faster than avg
Panel avg: 130d · This submission: 78d
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 Consultant

Olympus Corporation of the Americas
Daphney Germain-Kolawole

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - NEZ System, Imaging, Gastrointestinal, Wireless, Capsule

All 18
Devices cleared under the same product code (NEZ) and FDA review panel - the closest regulatory comparables to K163069.
Olympus Small Intestinal Capsule Endoscope System
K173459 · Olympus Medical Systems Corp. · Mar 2018
MiroCam Capsule Endoscope System
K170438 · Intromedic Co., Ltd. · Jan 2018
AdvanCE capsule endoscope delivery device
K163495 · United States Endoscopy Group, Inc. · Mar 2017
ENDOCAPSULE SOFTWARE 10
K142680 · Olympus Medical Systems Corp. · Feb 2015
OLYMPUS SMALL INTESTINAL CAPSULE ENDOSCOPE SYSTEM
K123421 · Olympus Medical Systems Corp. · Apr 2013
CAPSULE DELIVERY DEVICE, 160CM, MODEL 711143
K040494 · United States Endoscopy Group, Inc. · Jun 2004