Cleared Special

MODIFICATION TO OLYMPUS CAPSULE ENDOSCOPE SYSTEM (K090210) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K090210 · Olympus Medical Systems Corporation · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2009
Decision
182d
Days
Class 2
Risk

K090210 is an FDA 510(k) clearance for the MODIFICATION TO OLYMPUS CAPSULE ENDOSCOPE SYSTEM. Classified as System, Imaging, Gastrointestinal, Wireless, Capsule (product code NEZ), Class II - Special Controls.

Submitted by Olympus Medical Systems Corporation (Center Valley, US). The FDA issued a Cleared decision on July 29, 2009 after a review of 182 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1300 - 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.

View all Olympus Medical Systems Corporation devices

Submission Details

510(k) Number K090210 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 28, 2009
Decision Date July 29, 2009
Days to Decision 182 days
Submission Type Special
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
52d slower than avg
Panel avg: 130d · This submission: 182d
Pathway characteristics
Modification to existing cleared device.

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 46
Devices cleared under the same product code (NEZ) and FDA review panel - the closest regulatory comparables to K090210.
MiroCam® Capsule Endoscope System
K252617 · Intromedic Co., Ltd. · May 2026
CE Deliver (DLV)
K252480 · CapsoVision, Inc. · Dec 2025
CapsoCam Plus (SV-3) Capsule Endoscopy System
K242643 · CapsoVision, Inc. · Dec 2024
PillCam™ Genius SB System with PillCam Software v9.7 and PillCam Cloud Reader Software
K240276 · Given Imaging Ltd. (D.B.A. Medtronic) · May 2024
NaviCam Small Bowel Capsule Endoscopy System with NaviCam SB Capsule and NaviCam Tether
K233229 · Anx Robotica Corporation · Jan 2024
PillCam SB 3 capsule endoscopy system, PillCam Software 9.0E
K230991 · Given Imaging Ltd. (Medtronic) · Jun 2023