Cleared Special

K060475 - EVIS EXERA ULTRASONIC BRONCHOFIBERVIDEOSCOPE, OLYMPUS MODEL BF TYPE UC160F-OL8

K060475 is an FDA 510(k) clearance for EVIS EXERA ULTRASONIC BRONCHOFIBERVIDEO..., manufactured by Olympus Medical Systems Corporation. The device is a Class 2 Radiology device with product code ODB cleared through the Special 510(k) pathway after a 22-day FDA review.

K060475 · Olympus Medical Systems Corporation · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
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.

FDA 510(k) Submission Details - K060475

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
Combination Product No
PCCP Authorized No
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.

ODB Device Classification - Class 2, Special Controls

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.

Regulatory Consultant

Intertek Testing Services
NEIL E DEVINE

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.

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K060475 · EVIS EXERA ULTRASONIC BRONCHOFIBERVIDEOSCOPE, OLYMPUS MODEL BF TYPE UC160F-OL8
Download PDF FDA Summary Olympus Medical Syste…