Cleared Special

K060475 - EVIS EXERA ULTRASONIC BRONCHOFIBERVIDEOSCOPE, OLYMPUS MODEL BF TYPE UC160F-OL8 (FDA 510(k) Clearance)

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

K060475 · Olympus Medical Systems Corporation · Radiology device
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Optimized for regulatory review, auditing and printing
Mar 2006
Decision
22d
Days
Class 2
Risk

K060475 is an FDA 510(k) clearance for the EVIS EXERA ULTRASONIC BRONCHOFIBERVIDEOSCOPE, OLYMPUS MODEL BF TYPE UC160F-OL8. Classified as Endoscopic Contamination Prevention Sheath (product code ODB), Class II - Special Controls.

Submitted by Olympus Medical Systems Corporation (Melville, US). The FDA issued a Cleared decision on March 17, 2006 after a review of 22 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 876.1500 - the FDA radiology and imaging software oversight 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. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

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Submission Details

510(k) Number K060475 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 23, 2006
Decision Date March 17, 2006
Days to Decision 22 days
Submission Type Special
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
85d faster than avg
Panel avg: 107d · This submission: 22d
Pathway characteristics
Modification to existing cleared device. Third-party reviewed.

Device Classification

Product Code ODB Endoscopic Contamination Prevention Sheath
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition To Protect An Endoscope From Contamination By Providing A Barrier Between The Body And The Endoscope.
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 Radiology devices follow this clearance model.