Cleared Special

K090210 - MODIFICATION TO OLYMPUS CAPSULE ENDOSCOPE SYSTEM

K090210 is an FDA 510(k) clearance for MODIFICATION TO OLYMPUS CAPSULE ENDOSCO..., manufactured by Olympus Medical Systems Corporation. The device is a Class 2 Gastroenterology & Urology device with product code NEZ cleared through the Special 510(k) pathway after a 182-day FDA review.

K090210 · Olympus Medical Systems Corporation · Gastroenterology & Urology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (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.

FDA 510(k) Submission Details - K090210

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
51d slower than avg
Panel avg: 131d · This submission: 182d
Pathway characteristics
Modification to existing cleared device.

NEZ Device Classification - Class 2, Special Controls

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
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Download PDF FDA Summary Olympus Medical Syste…