Cleared Traditional

Olympus Small Intestinal Capsule Endoscope System (K173459) - FDA 510(k) Clearance

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

K173459 · Olympus Medical Systems Corp. · Gastroenterology & Urology device
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Optimized for regulatory review, auditing and printing
Mar 2018
Decision
126d
Days
Class 2
Risk

K173459 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-Shi, JP). The FDA issued a Cleared decision on March 13, 2018 after a review of 126 days - within the typical 510(k) review window.

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: 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 Olympus Medical Systems Corp. devices

Submission Details

510(k) Number K173459 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 07, 2017
Decision Date March 13, 2018
Days to Decision 126 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
4d faster than avg
Panel avg: 130d · This submission: 126d
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 K173459.
CapsoCam Plus (SV-3)
K183192 · CapsoVision, Inc. · Apr 2019
Olympus Small Intestinal Capsule Endoscope System
K183053 · Olympus Medical Systems Corp. · Mar 2019
MiroCam Capsule Endoscope System
K180732 · Intromedic Co., Ltd. · Nov 2018
MiroCam Capsule Endoscope System
K170438 · Intromedic Co., Ltd. · Jan 2018
AdvanCE capsule endoscope delivery device
K163495 · United States Endoscopy Group, Inc. · Mar 2017
OLYMPUS SMALL INTESTINAL CAPSULE ENDOSCOPE SYSTEM
K163069 · Olympus Medical Systems Corp. · Jan 2017